Pilot Study of Respiratory-gated Stereotactic Body Radiation Therapy for Borderline Resectable Unresectable or Recurrent/Residual Adenocarcinoma of the Pancreas or Periampullary Region
Research Study on Radiation Therapy for Pancreatic Cancer
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: Adenocarcinoma of the Pancreas or Periampullary Region,Adenocarcinoma,Pancreas,Periampullary Region,pancreas cancer,pancreatic cancer,cancer,oncology
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Age: 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
This study investigates the use of stereotactic body radiation therapy (SBRT) for treating pancreatic cancer. Pancreatic cancer, including cancer of the ampulla of Vater, is a type of cancer that affects the pancreas, an organ behind the stomach that helps with digestion. This study focuses on patients whose cancer cannot be removed by surgery, is close to being removable, or has come back after treatment.
Participants in this study will receive SBRT, a type of radiation therapy that targets tumors with high precision. This therapy aims to deliver radiation to the cancer cells while minimizing damage to nearby healthy tissue. Patients will be monitored for safety and any side effects related to the treatment.
- Who can participate: Adults with confirmed adenocarcinoma (a type of cancer) of the pancreas or ampulla of Vater, with tumors less than 8 cm, may participate. Participants should have completed prior treatments like chemotherapy or surgery at least 180 days ago. Acceptable organ function and a life expectancy greater than 3 months are required.
- Study details: Participants will undergo stereotactic body radiation therapy (SBRT). This involves precise targeting of the tumor with radiation. Participants must have radio-opaque markers (markers visible on X-rays) within the tumor bed to aid in treatment accuracy.
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