Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Stanford University
Study ID
NCT01926197
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
  • Irinotecan — DRUG
    Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
  • Leucovorin — DRUG
    Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
  • 5FU — DRUG
    5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
  • Stereotactic Body Radiotherapy (SBRT) — RADIATION
    Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.

Study Details

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.

Key Dates

Start date
Aug 14, 2013
Status verified
Oct 2022
Primary completion
Sep 30, 2021
Completion
Sep 30, 2022

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Modified FOLFIRINOX
    Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
  • Experimental: Modified FOLFIRINOX plus Stereotactic Body Radiotherapy
    Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 38 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia60153-
UCSFSan FranciscoCalifornia94143-
Stanford University, School of MedicineStanfordCalifornia94305-
Loyola UniversityMaywoodIllinois60153-
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of Texas Southwestern Medical CenterDallasTexas75390-
Swedish Cancer InstituteSeattleWashington98107-

Find similar trials in Los Angeles, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
UCLA· Los Angeles, CAUCSF· San Francisco, CAStanford University, School of Medicine· Stanford, CALoyola University· Maywood, ILMedical University of South Carolina· Charleston, SCUniversity of Texas Southwestern Medical Center· Dallas, TX

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