The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
Biopsy proven unresectable adenocarcinoma of the pancreas.
Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
Evidence of distant metastasis.
Prior surgical resection.
Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration.
Active or untreated infection,
Single group
Proton Radiation
RadiationProton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
Capecitabine
DrugConcomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Surgical resection
Procedure/SurgerySurgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.
Overall survival at 12 months after radiation therapy
The trial is designed to allow detection of an improvement in the 12 month overall survival rate to 75% compared to the expected historical rate of 50%.
Surgical resection rate.
Increase share of marginally resectable and unresectable patients being converted to resectable.
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Proton Collaborative Group
Lead sponsor
University of Florida Health
Collaborator
