Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas
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
2 other identifiers
interventional
34
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pancreatic-cancer
Started Jun 2012
Longer than P75 for phase_2 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedStudy Start
First participant enrolled
June 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2019
CompletedResults Posted
Study results publicly available
August 10, 2020
CompletedAugust 10, 2020
July 1, 2020
6.7 years
March 20, 2012
May 19, 2020
July 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Resectability Rate
Patients with borderline resectable treated with preoperative modified FOLFIRINOX chemotherapy, followed by gemcitabine-based chemoradiation therapy. At least 4- 6 weeks after the last dose of gemcitabine if there is no local progression or distant metastasis, patients were scheduled for surgery.
43 months
Secondary Outcomes (7)
Number of Participants With R0 Margin Resection
43 months
Disease Free Survival (DFS)
54 months
Number of Participants That Were SMAD4 Positive Before and After Surgery
43 months
Overall Survival
54 months
Number of Participants With Local and Distant Failure
43 months
- +2 more secondary outcomes
Study Arms (1)
Chemotherapy + Radiation
EXPERIMENTALSYSTEMIC 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.
Interventions
75 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
150 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
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.
350 mg/m2 by vein every week for 5 doses beginning Day 1 (days 1, 8, 15, 22, 29).
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).
Eligibility Criteria
You may qualify if:
- Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to treatment. Patients with Islet cell tumors are not eligible.
- Only untreated patients with high risk pancreatic adenocarcinomas will be eligible for the study. For this study, such patients are defined as those who meet one or more of the following radiographic or serologic criteria: a)Primary tumor that involves the superior mesenteric vein causing a vein deformity or segmental venous occlusion with a patent vessel above and below suitable for reconstruction. b)Primary tumor that involves \</= 180 degrees of the superior mesenteric artery (SMA), celiac axis or any of its branches on CT or MRI. c) Primary tumor that abuts or encases (\>/= 50% of the vessel circumference) a short segment of the common hepatic artery (typically at the gastroduodenal artery origin)
- (continuation of #2). d) Patients with a high CA19-9 (=/\>500mg/dl) in the presence of a bilirubin =/\< 2.0 mg/dL. e) Radiographic findings consistent with malignant peripancreatic lymphadenopathy outside the planned field on CT or MRI f) Radiographic findings of indeterminate liver or peritoneal lesions on CT or MRI concerning but not diagnostic of metastatic disease.
- Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, MRI or laparotomy.
- There will be no upper age restriction; patients with Eastern Cooperative Oncology Group (ECOG) 0-1 are eligible.
- Adequate renal, and bone marrow function: a) Leukocytes \>/= 3,000/uL. b) Absolute neutrophil count \>/=1,500/uL.c) Platelets \>/=100,000/Ul. d) Serum creatinine \</= 2.0 mg/dL.
- Hepatic function (endoscopic or percutaneous drainage as needed). a)Total bilirubin \</= 2 X institutional upper limits of normal (ULN). b) AST (SGOT)/ALT (SGPT) \</= 5 X institutional ULN.
- Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
- Women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding.
- Patients must sign a study-specific consent form.
You may not qualify if:
- Patients whose tumors are defined as locally advanced cancer or metastatic cancer are not eligible.
- Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure; multiple comorbidity that preclude a major abdominal surgery.
- Known presence of metastases.
- Inability to comply with study and/or follow-up procedures.
- Patients \< 18 years of age.
- Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study.
- Patients with an active second malignancy with the exception of non-melanoma skin cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gauri R Varadhachary,Professor, GI Medical Oncology
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Gauri Varadhachary, MD, MBBS
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2012
First Posted
March 22, 2012
Study Start
June 14, 2012
Primary Completion
February 20, 2019
Study Completion
February 20, 2019
Last Updated
August 10, 2020
Results First Posted
August 10, 2020
Record last verified: 2020-07