Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, Stereotactic Radiation
Brief summary
This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.
Interventions
RADIATIONStereotactic Radiation 10 Gy
10 Gy three times over 10 days
RADIATIONStereotactic Radiation 12.5 Gy
12.5 Gy three times over 10 days
RADIATIONStereotactic Radiation 15 Gy
15 Gy three times over 10 days
Sponsors
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma). * Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease. * Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT. * Age \> or = 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 (Karnofsky \> or = 60%) * Life expectancy of greater than 3 months. * Patients must have normal organ and marrow function. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity. * Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment. * Pregnancy. * Primary disease \> 7.5 cm in largest diameter as measured by CT or MRI. * Gross extension of tumor into the lumen of the duodenum. * 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. * Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (Phase 1) | 28 days | Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Eligible for Surgery to Remove Tumor After Treatment | 12 months after treatment | — |
| Number of Patients With Local Disease Control | 12 months after treatment | Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria |
| The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity | 12 months after treatment | Grade 3+ GI late toxicity |
| Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale | 12 months after treatment | Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response. |
| Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. | 12 months after treatment | The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180). |
Countries
United States
Participant flow
Pre-assignment details
Excluded Patients (n = 2) due to screening failures
Participants by arm
| Arm | Count |
|---|---|
| Stereotactic Radiation: 10 Gy x3 Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy). | 3 |
| Stereotactic Radiation: 12.5 Gy x3 Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy). | 3 |
| Stereotactic Radiation: 15 Gy x3 Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy). | 9 |
| Total | 15 |
Baseline characteristics
| Characteristic | Stereotactic Radiation: 10 Gy x3 | Stereotactic Radiation: 12.5 Gy x3 | Stereotactic Radiation: 15 Gy x3 | Total |
|---|---|---|---|---|
| Age, Continuous | 65 years | 55 years | 61 years | 61 years |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 1 Participants | 7 Participants | 10 Participants |
| Region of Enrollment United States | 3 participants | 3 participants | 9 participants | 15 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 3 / 3 | 9 / 9 |
| other Total, other adverse events | 1 / 3 | 3 / 3 | 7 / 9 |
| serious Total, serious adverse events | 2 / 3 | 0 / 3 | 2 / 9 |
Outcome results
Primary
Maximum Tolerated Dose (Phase 1)
Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiation | Maximum Tolerated Dose (Phase 1) | 45 Gy |
Secondary
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.
The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180).
Time frame: 12 months after treatment
Population: This measure was added to the study protocol when accrual for the third cohort began and thus was only assessed in the third (15 Gy x3) cohort. Among this cohort, baseline data was only collected for 5 patients and only 1 of these patients had 12 month data, which was optional, and that is what is summarized here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stereotactic Radiation: 15 Gy x3 | Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. | Baseline | 142 score on a scale | Standard Deviation 24 |
| Stereotactic Radiation: 15 Gy x3 | Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. | 12 months | 157 score on a scale | Standard Deviation 0 |
Secondary
Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale
Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response.
Time frame: 12 months after treatment
Population: Only eight patients of enrolled patients across all dose levels had pain at presentation and were eligible for this secondary outcome of pain response
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stereotactic Radiation | Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale | 3 Participants |
| Stereotactic Radiation: 12.5 Gy x3 | Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale | 0 Participants |
| Stereotactic Radiation: 15 Gy x3 | Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale | 2 Participants |
Secondary
Number of Patients Eligible for Surgery to Remove Tumor After Treatment
Time frame: 12 months after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiation | Number of Patients Eligible for Surgery to Remove Tumor After Treatment | 0 participants |
| Stereotactic Radiation: 12.5 Gy x3 | Number of Patients Eligible for Surgery to Remove Tumor After Treatment | 0 participants |
| Stereotactic Radiation: 15 Gy x3 | Number of Patients Eligible for Surgery to Remove Tumor After Treatment | 0 participants |
Secondary
Number of Patients With Local Disease Control
Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria
Time frame: 12 months after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiation | Number of Patients With Local Disease Control | 3 participants |
| Stereotactic Radiation: 12.5 Gy x3 | Number of Patients With Local Disease Control | 3 participants |
| Stereotactic Radiation: 15 Gy x3 | Number of Patients With Local Disease Control | 5 participants |
Secondary
The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity
Grade 3+ GI late toxicity
Time frame: 12 months after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiation | The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity | 2 participants |
| Stereotactic Radiation: 12.5 Gy x3 | The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity | 0 participants |
| Stereotactic Radiation: 15 Gy x3 | The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity | 2 participants |