Pilot Study of Respiratory-gated Stereotactic Body Radiation Therapy for Borderline Resectable Unresectable or Recurrent/Residual Adenocarcinoma of the Pancreas or Periampullary Region
Ryan Rhome, MD
Primary Investigator
Brief description of study
This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated radiation treatment, or any combination of these therapies.
Detailed description of study
The purpose of this study is to evaluate stereotactic body radiation therapy (SBRT) for cancer of the pancreas.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: pancreatic cancer
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
Histologically confirmed adenocarcinoma of the pancreas or ampulla of Vater; at least the majority of the histopathologic specimen must be identified as adenocarcinoma as opposed to another histologic subtype.
Pancreatic or periampullary tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning
Patients who have been treated with any combination of surgical resection and neoadjuvant/adjuvant conventional chemoradiation therapy for resectable disease or conventional chemoradiation as definitive treatment for unresectable or borderline resectable disease are eligible for the study, provided that at least 180 days have elapsed since completing any previous radiation treatment
Patients who have not previously undergone radiation therapy can have a history of treatment with either chemotherapy (for unresectable/borderline resectable disease) or any combination of surgery and chemotherapy (for resectable disease)
Acceptable organ and marrow function
Life expectancy > 3 months
Radio-opaque markers must be present within the tumor bed
Exclusion Criteria
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix
Pregnant and breastfeeding women are excluded as are women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Patients with a life expectancy of 3 months
Patients with metastatic disease
Patients with evidence of gross tumor invasion into the lumen of the stomach or small bowel are not eligible; if imaging suggests luminal invasion of tumor, this must be ruled out endoscopically before the patient can be enrolled on study
