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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

October 31, 2039

Study Completion Date

October 31, 2040

Conditions
Pancreatic Cancer
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.

Trial Locations (4)

22031

RECRUITING

Inova Schar Cancer Institute, Fairfax

32206

ACTIVE_NOT_RECRUITING

University of Florida Proton Therapy Institute, Jacksonville

48532

RECRUITING

McLaren Proton Therapy Center, Flint

60555

RECRUITING

Northwestern Medicine Chicago Proton Center, Warrenville

All Listed Sponsors
collaborator

University of Florida Health

OTHER

lead

Proton Collaborative Group

NETWORK

NCT02598349 - Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas | Biotech Hunter | Biotech Hunter