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

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ClinicalTrials.gov Identifier: NCT01926197
Recruitment Status : Recruiting
First Posted : August 20, 2013
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 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 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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



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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926197


Contacts
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Contact: Samantha Wong 650-498-8495 swong8@stanford.edu

Locations
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United States, California
UCLA Active, not recruiting
Los Angeles, California, United States, 60153
UCSF Active, not recruiting
San Francisco, California, United States, 94143
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Samantha Wong    650-498-8495    swong8@stanford.edu   
Principal Investigator: Daniel T Chang         
United States, Illinois
Loyola University Recruiting
Maywood, Illinois, United States, 60153
Contact: Beth Chiappetta, RN    708-216-2568    BCHIAPPETTA@lumc.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: David Marshall, MD    843-792-3273    marshadt@musc.edu   
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Jeffrey Meyer, MD,MS    214-645-7604    Jeffrey.Meyer@UTSouthwestern.edu   
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98107
Contact: Vivek Mehta       Vivek.Mehta@swedish.org   
Canada, British Columbia
BC Cancer Agency Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Laura Dawson    416-946-2127 ext 4820    Laura.Dawson@rmp.uhn.on.ca   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Daniel T Chang Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01926197     History of Changes
Other Study ID Numbers: PANC0015
IRB-27492 ( Other Identifier: Stanford IRB )
NCI-2013-01658 ( Other Identifier: NCI )
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action