Proton Radiation for Pancreatic Cancer That Cannot Be Removed by Surgery
Sponsor: Proton Collaborative Group
ClinicalTrials ID:NCT02598349
This study is exploring whether using proton radiation combined with an oral chemotherapy drug, capecitabine, can help more patients with pancreatic cancer become eligible for surgery and improve their overall outcomes.
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Program Overview
This research is focused on patients with pancreatic cancer that cannot be removed by surgery. The study aims to find out if using proton radiation along with the chemotherapy drug capecitabine can increase the number of patients who can eventually have surgery and improve their chances of controlling the disease and living longer.
Description
Participants in this study will receive proton radiation treatment over a period of 6 weeks. During this time, they will also take an oral chemotherapy drug called capecitabine, but only on the days they receive radiation. If surgery becomes an option, it will be scheduled at least 8 weeks after completing the radiation and chemotherapy treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of pancreatic cancer that cannot be removed by surgery.
- Have pancreatic cancer that is either not removable, borderline removable, or cannot be operated on due to medical reasons, or have chosen not to have surgery.
- If there is a bile duct blockage, a drainage tube must be in place before starting proton radiation treatment.
- Participants who can have children must agree to use birth control during treatment and for at least 12 months after.
- Must meet certain blood test requirements before starting treatment:
- Granulocyte count of at least 1.8 thou/mm3
- Platelet count of at least 100,000/mm3
- Bilirubin level less than 2 mg/dl
- ALT/SGPT level less than 3 times the normal limit
- Creatinine level less than 3 mg/dl
Exclusion Criteria
- Have cancer that has spread to other parts of the body.
- Have had previous surgery to remove pancreatic cancer.
- Have had another invasive cancer in the past, unless it was non-melanoma skin cancer or low to intermediate risk prostate cancer, and have been cancer-free for 5 years.
- Have an active or untreated infection.
- Are pregnant or breastfeeding, or can have children and are not willing to use birth control during treatment and for at least 12 months after.
- Have had previous radiation treatment to the abdomen.
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