Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01560949
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    75 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
  • Irinotecan — DRUG
    150 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
  • 5-FU — DRUG
    2000 mg/m2 by vein over 46 hour continuous infusion, on Days 1 - 2 during weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
  • Gemcitabine — DRUG
    350 mg/m2 by vein every week for 5 doses beginning Day 1 (days 1, 8, 15, 22, 29).
  • Radiation Therapy — RADIATION
    External beam radiation therapy delivered 5 days/week +/- 2 days over 5.5 weeks with 18-MeV photons. 3D conformal RT, a total dose of 50.4 Gy 1.8 Gy/fraction (28 fractions).

Study Details

The goal of this clinical research study is to learn if a chemotherapy combination called modified Folfirinox (or mFolfirinox), followed by a combination of gemcitabine and radiation therapy, followed by surgery, can help to control pancreatic cancer. The safety of this treatment will also be studied. mFolfirinox consists of 5-FU, oxaliplatin, and irinotecan. These 3 drugs, along with gemcitabine, are each designed to block the growth of cancer cells, which may lead to cancer cell death.

Key Dates

Start date
Jun 14, 2012
Status verified
Jul 2020
Primary completion
Feb 20, 2019
Completion
Feb 20, 2019

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy + Radiation
    SYSTEMIC PHASE: Chemotherapy with Oxaliplatin followed by Irinotecan followed by 5-FU. m FOLFIRINOX - oxaliplatin 75 mg/m2 d1 + irinotecan 150 mg/m2 d1 + 5-FUl 2,000 mg/m2 46h continuous infusion, every other week for 6 cycles (12 weeks). CHEMORADIATION PHASE: This phase will start at least 2 weeks, but no more than 6 weeks after completion of the last cycle of mFOLFIRINOX. Chemoradiation with Gemcitabine: 350 mg/m2 IV over 35 minutes every week for 5 doses beginning day 1 (days 1, 8, 15, 22, 29) Radiation: External beam radiation therapy will be delivered 5 days/week +/- 2 days over 5.5 weeks with 18-MeV photons. 3D conformal RT, a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions) to the GTV + 1.5 cm margin. SURGERY- At least 4-6 weeks after last dose of Gemcitabine, if no local progression or distant metastasis. Patients whose scans show unequivocal local or distant progression are not candidates for surgery.

Primary Outcome Measure

Number of Participants With Resectability Rate [ Time Frame: 43 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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