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

NCT01926197 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-10-28

Study results available
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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.

Conditions

Interventions

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.

DRUG

Irinotecan

Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.

DRUG

Leucovorin

Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.

DRUG

5FU

5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.

RADIATION

Stereotactic Body Radiotherapy (SBRT)

Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.

Sponsors & Collaborators

Principal Investigators

  • Daniel T Chang · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-14
Primary Completion
2021-09-30
Completion
2022-09-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01926197 on ClinicalTrials.gov