Clinical trial · Interventional
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
NCT01560949CI-TRIAL-00046522completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy + Radiation
- description
- 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.
- interventionNames
- Drug: Oxaliplatin
- Drug: Irinotecan
- Drug: 5-FU
- Drug: Gemcitabine
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Number of Participants With Resectability Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to treatment. Patients with Islet cell tumors are not eligible. 2. 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) 3. (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. 4. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, MRI or laparotomy. 5. There will be no upper age restriction; patients with Eastern Cooperative Oncology Group (ECOG) 0-1 are eligible. 6. 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. 7. 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. 8. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy. 9. 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. 10. Patients must sign a study-specific consent form. Exclusion Criteria: 1. Patients whose tumors are defined as locally advanced cancer or metastatic cancer are not eligible. 2. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure; multiple comorbidity that preclude a major abdominal surgery. 3. Known presence of metastases. 4. Inability to comply with study and/or follow-up procedures. 5. Patients \< 18 years of age. 6. Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study. 7. Patients with an active second malignancy with the exception of non-melanoma skin cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.