Study of Proton Therapy in Adjuvant Pancreatic Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

July 15, 2019

Primary Completion Date

May 24, 2022

Study Completion Date

November 8, 2023

Conditions
Resected Pancreatic Adenocarcinoma
Interventions
DRUG

mFOLFIRINOX

"Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:~* Irinotecan 150 mg/m2 IV day 1~* Oxaliplatin 85 mg/m2 IV day 1~* Leucovorin 400 mg/m2 IV day 1~* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)~* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)~* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3."

RADIATION

Proton beam radiation

Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7

Trial Locations (1)

20007

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center, Washington D.C.

All Listed Sponsors
lead

Georgetown University

OTHER

NCT03885284 - Study of Proton Therapy in Adjuvant Pancreatic Cancer | Biotech Hunter | Biotech Hunter