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Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer

NCT02839343 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-05-24

Study results available
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Summary

This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.

Conditions

  • Pancreatic Adenocarcinoma
  • Borderline Resectable Adenocarcinoma of the Head of the Pancrease

Interventions

RADIATION

radiation therapy

PROCEDURE

surgery

DRUG

mFOLFIRINOX

oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV

DRUG

FOLFOX

oxaliplatin IV, leucovorin IV and 5-FU IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sky Foundation

    collaborator OTHER

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Matthew Katz, MD, FACS · The University of Texas MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT02839343 on ClinicalTrials.gov