Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas
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.
Radiation: Radiation Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Preoperative Systemic Chemotherapy (Modified FOLFIRINOX) Followed by Radiation Therapy for Patients With High Risk Resectable and Borderline Resectable Adenocarcinoma of the Pancreas|
- Resection Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Resectability rate defined as proportion of participants who undergo surgery among all enrolled participants. The Simon's optimum two-stage design is applied in this study. Sample size of 66 is chosen to differentiate between good resectability rate of 60% and poor resectability rate of 40% with 90% power and at a significance level of 0.05. Resectability rate estimated, along with the 95% confidence interval, using intent-to-treat (ITT) principle.
- Overall Survival [ Time Frame: 2 months after surgery ] [ Designated as safety issue: No ]Overall survival measured from time of histologic or cytologic diagnosis of pancreatic adenocarcinoma. Kaplan-Meier method used to assess overall survival (OS), progression-free survival (PFS) and disease-free survival (DFS). Assessment of status of DPC4 (positive versus negative) preoperative and after surgery and to evaluate association between the DPC4 status and survival endpoints. CTCs also measured from blood drawn at baseline, post treatment-presurgery, during surgery and 2-3 months after surgery.
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
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.
75 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
Other Name: EloxatinDrug: Irinotecan
150 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
Other Names:Drug: 5-FU
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.
Other Names:Drug: Gemcitabine
350 mg/m2 by vein every week for 5 doses beginning Day 1 (days 1, 8, 15, 22, 29).
Other Names:Radiation: Radiation Therapy
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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01560949
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gauri Varadhachary, MD, MBBS||M.D. Anderson Cancer Center|