Phase 3
N=27
Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01926197 ↗Enrolled (actual)
27
Serious AEs
48.0%
Results posted
Oct 2022
Primary outcome: Primary: Progression-free Survival (PFS) — 6.5; 8.4 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oxaliplatin (Drug); Irinotecan (Drug); Leucovorin (Drug); 5FU (Drug); Stereotactic Body Radiotherapy (SBRT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
6.5; 8.4 | — |
| SECONDARY Local Progression-free Survival (Local PFS) |
6.5; 8.4 | — |
| SECONDARY Progression-free Survival (PFS) at 1 Year |
5; 2 | — |
| SECONDARY Metastasis-free Survival (MFS) |
12.9; 10.8 | — |
| SECONDARY Overall Survival (OS) |
12.9; 13.4 | — |
| SECONDARY Grade 2 or Greater Gastrointestinal (GI) Toxicity |
1; 0; 1; 0; 1; 0 | — |
Summary
The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.
Eligibility Criteria
INCLUSION CRITERIA
- Histologically-confirmed adenocarcinoma of the pancreas
- Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board.
- Stable or better disease on re-staging scans
- Typically, tumors 6 months
EXCLUSION CRITERIA
- Metastatic disease
- Prior radiotherapy to the upper abdomen/liver.
- Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified FOLFIRINOX.
- Age 5 years will be allowed to enter the trial.
- Pregnant or lactating
- Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) for duration of the study
- Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
- Male subjects who are unwilling or unable to use effective contraception for duration of the study
Data sourced from ClinicalTrials.gov (NCT01926197). 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.