Thyroid Cancer
Conditions
Keywords
non-anaplastic, non-medullary, radiation, IMRT, Doxorubicin, 13-070
Brief summary
The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present.
Interventions
RADIATIONIMRT
Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC
DEVICEDWI MRI
The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.
DRUGDoxorubicin
Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.
OTHERModified Barium Swallow Impairment Profile (MBSImP)
The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Sponsors
Memorial Sloan Kettering Cancer Center
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
* Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease. * Age ≥18 years * Karnofsky performance status ≥70% * Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment. * Patients must have ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Women who are pregnant or lactating * Inability to comply with study and/or follow-up procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local-regional Progression-free Survival | 2 years | 2-year cumulative incidence of locoregional progression/failure with death as a competing risk will be defined as infield progression if included in the RT field and meets one of the following criteria: 25% increase in tumor volume, new lesions, and/or 25% increase in metabolic tumor volume or total lesion glycolysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Late Xerostomia/Dry Mouth | 2 years | Rate of late xerostomia/dry mouth. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 |
| Overall Survival | 2 years | — |
| Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities | 2 years | During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 Physician-reported acute grade 3 or higher treatment-related toxicities, regardless of attribution. |
| Rate of Late Dysphagia | 2 years | Grade 2 or higher late toxicity rate. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 |
| Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | 12 months | Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IMRT and Doxorubicin All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
IMRT: Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC
DWI MRI: The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.
Doxorubicin: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.
Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | IMRT and Doxorubicin |
|---|---|
| Age, Continuous | 45.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 27 |
| other Total, other adverse events | 22 / 27 |
| serious Total, serious adverse events | 3 / 27 |
Outcome results
Primary
Percentage of Participants With Local-regional Progression-free Survival
2-year cumulative incidence of locoregional progression/failure with death as a competing risk will be defined as infield progression if included in the RT field and meets one of the following criteria: 25% increase in tumor volume, new lesions, and/or 25% increase in metabolic tumor volume or total lesion glycolysis.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMRT and Doxorubicin | Percentage of Participants With Local-regional Progression-free Survival | 15.2 percentage of all participants |
Secondary
Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline
Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IMRT and Doxorubicin | Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | Participants with significant functional difference as compared to baseline | 0 Participants |
| IMRT and Doxorubicin | Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | Participants without significant functional difference as compared to baseline | 27 Participants |
Secondary
Overall Survival
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMRT and Doxorubicin | Overall Survival | 77.3 percentage of participants alive |
Secondary
Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities
During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 Physician-reported acute grade 3 or higher treatment-related toxicities, regardless of attribution.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMRT and Doxorubicin | Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities | 33.4 percentage of participants |
Secondary
Rate of Late Dysphagia
Grade 2 or higher late toxicity rate. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMRT and Doxorubicin | Rate of Late Dysphagia | 8.0 percent of pts experiencing dysphagia |
Secondary
Rate of Late Xerostomia/Dry Mouth
Rate of late xerostomia/dry mouth. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMRT and Doxorubicin | Rate of Late Xerostomia/Dry Mouth | 4.0 percent of pts experiencing dry mouth |