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).
Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days. In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Proton 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.
Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
ACTIVE_NOT_RECRUITINGNorthwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
RECRUITINGMcLaren Proton Therapy Center
Flint, Michigan, United States
RECRUITINGInova Schar Cancer Institute
Fairfax, Virginia, United States
RECRUITINGOverall 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%.
Time frame: Approximately 12 months after radiation therapy.
Surgical resection rate.
Increase share of marginally resectable and unresectable patients being converted to resectable.
Time frame: 3 months following the completion of radiation therapy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.