Phase 2
N=33
Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01560949 ↗Enrolled (actual)
33
Serious AEs
9.5%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants With Resectability Rate — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxaliplatin (Drug); Irinotecan (Drug); 5-FU (Drug); Gemcitabine (Drug); Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Resectability Rate |
15 | — |
| SECONDARY Number of Participants With R0 Margin Resection |
10 | — |
| SECONDARY Disease Free Survival (DFS) |
11.1 | — |
| SECONDARY Number of Participants That Were SMAD4 Positive Before and After Surgery |
4; 4 | — |
| SECONDARY Overall Survival |
24 | — |
| SECONDARY Number of Participants With Local and Distant Failure |
0; 10 | — |
| SECONDARY Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Pre-Surgery |
4; 2 | — |
| SECONDARY Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Post-Surgery |
4; 7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 /= 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 =/ /= 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01560949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.