Anus Neoplasms, Endometrial Neoplasms, Prostatic Neoplasms, Rectal Neoplasms, Uterine Cervical Neoplasms
Conditions
Keywords
radiotherapy, Positron-Emission Tomography and Computed Tomography, chemotherapy, bone marrow
Brief summary
\[F-18\] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration.
Detailed description
Overall survival of pelvic cancer patients depends on control of systemic disease. If local radiation therapy depletes bone marrow function to such an extent that systemic therapies must be withheld, chances of metastatic failure increase significantly. This may be more significant for this group of patients because approximately one third of adult bone marrow is located in the pelvic region. Strategies to minimize toxicities would benefit a range of pelvic cancer patients including gynecologic, anal, rectal, and prostate. New chemoradiation combinations improve outcomes for these disease sites, but come at the cost of higher levels of toxicity. As many as 40% of cervical cancer patients miss at least one chemotherapy cycle due to hematologic toxicity and 36% of anal cancer patients experience grade 3 or 4 hematologic toxicity when undergoing chemoradiation therapy. A clinical trial of concurrent chemoradiation therapy for rectal cancer was terminated due to toxicity, including hematologic toxicities. Concurrent chemoradiation therapy shows promise for advanced stage prostate cancers, but it also increases grade 3 and 4 toxicities. To successfully limit hematologic toxicities for pelvic cancers, it is extremely advantageous to avoid irradiating the highly proliferative compartments of the pelvic bone marrow. However, the complex structure of the pelvis makes it difficult to assess the efficacy of radiation therapy (RT) planning strategies to avoid areas critical to hematopoiesis. Uptake of \[18F\]fluorothymidine imaged with positron emission tomography (FLT PET/CT) can be an accurate and sensitive tool for identifying and monitoring the effects of chemoradiation on proliferative pelvic bone marrow. Clinically validating the utility of FLT PET/CT imaging for identifying active bone marrow in the design of bone marrow sparing RT-plans and the important bone marrow assessment time points would provide a method to reduce acute and chronic hematologic toxicities for pelvic cancer patients.
Interventions
DRUGfluorothymidine F 18
A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
John M. Buatti
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to understand and willingness to sign a written informed consent document. * Recommended to undergo pelvic irradiation with concurrent chemotherapy. * At least 18 years of age. Pediatrics would be best served by a protocol designed for their specific needs. * Karnofsky Performance Status of at least 60% at time of screening. * Life expectancy of greater than 6 months. * Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment: * leukocytes at least 3,000 / µL * absolute neutrophil count of at least 1500 / µL * platelets of at least 100,000 / µL * creatinine equal to or less than the upper limit of normal * not pregnant (as applicable)
Exclusion criteria
* history of allergic reactions attributed to compounds of similar chemical or biologic composition to FLT * an oncology research protocol requiring full pelvic radiation (i.e., 4 field box technique) * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Difference From Baseline IMRT Plan (%) | Baseline (pre-treatment) | The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy Compliance | At 24 months | The number of participants who had chemotherapy withheld at least once for low blood counts. |
| Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment | White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment | Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment | Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up |
| Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment | Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FLT PET/CT FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.
Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | FLT technical failure | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | FLT PET/CT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Region of Enrollment United States | 36 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 6 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Percent Difference From Baseline IMRT Plan (%)
The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.
Time frame: Baseline (pre-treatment)
Population: All participants who received an FLT PET/CT during radiation simulation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Basline FLT PET/CT (All Subjects) | Percent Difference From Baseline IMRT Plan (%) | % difference, volume receiving 5 Gray | -4.7 Percent difference (%) | Standard Deviation 3.3 |
| Basline FLT PET/CT (All Subjects) | Percent Difference From Baseline IMRT Plan (%) | % difference, volume receiving 10 Gray | -9.3 Percent difference (%) | Standard Deviation 4.2 |
| Basline FLT PET/CT (All Subjects) | Percent Difference From Baseline IMRT Plan (%) | % difference, volume receiving 20 Gray | -14.2 Percent difference (%) | Standard Deviation 4.1 |
| Basline FLT PET/CT (All Subjects) | Percent Difference From Baseline IMRT Plan (%) | % difference, volume receiving 30 Gray | -13.4 Percent difference (%) | Standard Deviation 7.6 |
| Basline FLT PET/CT (All Subjects) | Percent Difference From Baseline IMRT Plan (%) | % difference, dose to target (tumor) volume | -0.1 Percent difference (%) | Standard Deviation 0.4 |
Secondary
Chemotherapy Compliance
The number of participants who had chemotherapy withheld at least once for low blood counts.
Time frame: At 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basline FLT PET/CT (All Subjects) | Chemotherapy Compliance | 7 Participants |
Secondary
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Population: This group includes all tumor types treated in this clinical trial and provides an overall averages.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 0 (no toxicity) | 27 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 1 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Baseline (pre-treatment) | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 0 (no toxicity) | 25 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 1 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 1 | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 1 | 8 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 3 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | CTCAE grade 4 (most severe) | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 2 | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 1 | 4 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 3 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 3 | Not assessed (test omitted) | 6 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 0 (no toxicity) | 17 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 1 | 5 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 2 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 4 | Not assessed (test omitted) | 3 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 0 (no toxicity) | 13 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 1 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 2 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | Therapy, week 5 | Not assessed (test omitted) | 10 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 0 (no toxicity) | 21 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 1 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 30 days post-therapy | Not assessed (test omitted) | 5 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 1 year post-therapy | CTCAE grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 1 year post-therapy | CTCAE grade 1 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 1 year post-therapy | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 1 year post-therapy | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 1 year post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs) | 1 year post-therapy | Not assessed (test omitted) | 9 Participants |
Secondary
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Population: This group includes all tumor types treated in this clinical trial and provides an overall averages.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 0 (no toxicity) | 27 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 1 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Baseline (pre-treatment) | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 0 (no toxicity) | 25 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 1 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 1 | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 1 | 8 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 3 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | CTCAE grade 4 (most severe) | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 2 | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 1 | 4 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 3 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 3 | Not assessed (test omitted) | 6 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 0 (no toxicity) | 17 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 1 | 5 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 2 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 4 | Not assessed (test omitted) | 3 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 0 (no toxicity) | 13 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 1 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 2 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | Therapy, week 5 | Not assessed (test omitted) | 10 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 0 (no toxicity) | 21 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 1 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 30 days post-therapy | Not assessed (test omitted) | 5 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 1 year post-therapy | CTCAE grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 1 year post-therapy | CTCAE grade 1 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 1 year post-therapy | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 1 year post-therapy | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 1 year post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts. | 1 year post-therapy | Not assessed (test omitted) | 9 Participants |
Secondary
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Population: This group includes all tumor types treated in this clinical trial and provides an overall averages.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 0 (no toxicity) | 27 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 1 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | CTCAE grade 4 (severe toxicity) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Baseline (pre-treatment) | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 0 (no toxicity) | 27 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 1 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | CTCAE grade 4 (severe toxicity) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 1 | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 1 | 9 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 3 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | CTCAE grade 4 (severe toxicity) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 2 | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 0 (no toxicity) | 12 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 1 | 6 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 2 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 3 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | CTCAE grade 4 (severe toxicity) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 3 | Not assessed (test omitted) | 7 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 0 (no toxicity) | 15 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 1 | 6 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 2 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | CTCAE grade 4 (severe toxicity) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 4 | Not assessed (test omitted) | 4 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 0 (no toxicity) | 9 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 1 | 7 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 2 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | CTCAE grade 4 (severe toxicity) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | Therapy, week 5 | Not assessed (test omitted) | 10 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 0 (no toxicity) | 17 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 1 | 4 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 2 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | CTCAE grade 4 (severe toxicity) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 30 days post-therapy | Not assessed (test omitted) | 5 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 1 year post-therapy | CTCAE grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 1 year post-therapy | CTCAE grade 1 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 1 year post-therapy | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 1 year post-therapy | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 1 year post-therapy | CTCAE grade 4 (severe toxicity) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts. | 1 year post-therapy | Not assessed (test omitted) | 9 Participants |
Secondary
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment
Population: This group includes all tumor types treated in this clinical trial and provides an overall averages.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | Grade 0 (no toxicity) | 27 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 1 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Baseline (pre-treatment) | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | Grade 0 (no toxicity) | 27 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 1 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 1 | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | Grade 0 (no toxicity) | 15 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 1 | 7 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 2 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 3 | 3 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | CTCAE grade 4 (most severe) | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 2 | Not assessed (test omitted) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | Grade 0 (no toxicity) | 13 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 1 | 5 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 2 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 3 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 3 | Not assessed (test omitted) | 6 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | Grade 0 (no toxicity) | 13 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 1 | 5 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 2 | 4 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 3 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 4 | Not assessed (test omitted) | 3 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | Grade 0 (no toxicity) | 10 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 1 | 3 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 2 | 3 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 3 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | Therapy, week 5 | Not assessed (test omitted) | 10 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | Grade 0 (no toxicity) | 20 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 1 | 2 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 2 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 30 days post-therapy | Not assessed (test omitted) | 5 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 1 year post-therapy | Grade 0 (no toxicity) | 16 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 1 year post-therapy | CTCAE grade 1 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 1 year post-therapy | CTCAE grade 2 | 1 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 1 year post-therapy | CTCAE grade 3 | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 1 year post-therapy | CTCAE grade 4 (most severe) | 0 Participants |
| Basline FLT PET/CT (All Subjects) | Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts | 1 year post-therapy | Not assessed (test omitted) | 9 Participants |