Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer

Phase 1

Completed

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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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).