MedTrace Logo

Study of Proton Therapy in Adjuvant Pancreatic Cancer

NCT03885284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-10-24

Study results available
· View outcomes & findings →

Summary

This trial aims to determine a safe schedule of short-course proton beam radiation therapy with adjuvant mFOLFIRINOX for patients with resected pancreatic adenocarcinoma.

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

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • Benjamin Weinberg, MD · Georgetown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2022-05-24
Completion
2023-11-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03885284 on ClinicalTrials.gov