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RECRUITING
NCT02598349
PHASE2

Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas

Sponsor: Proton Collaborative Group

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2016-04

Completion Date

2040-10

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

RADIATION

Proton Radiation

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.

DRUG

Capecitabine

Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.

PROCEDURE

Surgical resection

Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.

Locations (4)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, United States

McLaren Proton Therapy Center

Flint, Michigan, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States