Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT01926197
• Recruitment Status: Active, not recruiting
• First Posted: August 20, 2013
• Last Update Posted: January 22, 2021
• Sponsor: Stanford University
• Information provided by (Responsible Party): Stanford University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Drug: Oxaliplatin; Radiation: SBRT; Drug: Irinotecan; Drug: Leucovorin; Drug: 5FU	Phase 3

Detailed Description:

A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial

Primary Objective:

To determine progression free survival for mFFX +/- SBRT.

Secondary Objectives:

• To determine metastasis free survival following mFFX chemotherapy alone or with SBRT.
• To determine the overall survival in pancreatic cancer patients treated with chemotherapy +/- SBRT.
• To determine local progression-free survival in pancreatic cancer patients after chemotherapy +/- SBRT.
• To evaluate acute (within 3 months of treatment) grade 2 or greater gastritis, fistula, enteritis, or ulcer and any other grade 3-4 gastrointestinal toxicity within 3 months of treatment.
• To evaluate the utility of FDG-PET for treatment planning and estimation of progression free survival.
• To identify new biomarkers in pancreatic cancer.
• To evaluate the quality of life of patients before and after either chemotherapy or chemotherapy and SBRT.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer
• Study Start Date: August 2013
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: mFFX; mFOLFIRINOX	Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5FU
Experimental: mFFX+SBRT; mFOLFIRINOX + SBRT	Drug: Oxaliplatin; Radiation: SBRT; Drug: Irinotecan; Drug: Leucovorin; Drug: 5FU

Outcome Measures

Primary Outcome Measures :

1. difference in progression-free survival between mFOLFIRINOX alone vs. mFOLFIRINOX and SBRT [ Time Frame: one year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the pancreas.
• Induction mFolfirinox up to 4 cycles. Informed consent must be signed by the end of the second cycle.
• Stable or better disease on re-staging scans.
• Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board.
• Typically, pancreatic tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning but final determination of eligibility will be based upon satisfying the radiation normal tissue constraints as per protocol.
• ECOG 0, 1, or 2

• Patients must have acceptable organ and marrow function as defined below and within 30 days of eligibility confirmation:

  • leukocytes (WBC) >=3,000/mL
  • absolute neutrophil count (ANC)>=1,500mL
  • platelets >=50,000/mL
  • total bilirubin < or = 1.5 X institutional upper limit of normal
  • AST(SGOT)/ALT(SGPT) < or =2.5 X institutional upper limit of normal
  • creatinine within normal institutional limits
• Ability to understand and the willingness to sign an informed consent form.
• Life expectancy > 6 months.

Exclusion Criteria:

• Metastatic disease
• Patients who have had prior radiotherapy to the upper abdomen/liver.
• Patients who have received chemotherapy for pancreatic cancer, other than up to 4 cycles of mFolfirinox.
• Children are excluded because pancreatic tumors rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial.
• Pregnant and breastfeeding women are excluded; as well as 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) to avoid pregnancy for the duration of the study. Male subjects must also agree to use effective contraception for the same period as above. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• 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

Contacts and Locations

Locations

United States, California

UCLA

Los Angeles, California, United States, 60153

UCSF

San Francisco, California, United States, 94143

Stanford University, School of Medicine

Stanford, California, United States, 94305

United States, Illinois

Loyola University

Maywood, Illinois, United States, 60153

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

United States, Washington

Swedish Cancer Institute

Seattle, Washington, United States, 98107

Canada, British Columbia

BC Cancer Agency

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Ontario

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Daniel T Chang; Stanford University

More Information

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT01926197
• Other Study ID Numbers: IRB-27492; PANC0015 ( Other Identifier: OnCore ); NCI-2013-01658 ( Other Identifier: NCI )
• First Posted: August 20, 2013
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Leucovorin; Oxaliplatin; Irinotecan; Antineoplastic Agents; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antidotes; Protective Agents; Physiological Effects of Drugs; Vitamin B Complex; Vitamins; Micronutrients; Nutrients; Growth Substances