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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01926197
First received: August 15, 2013
Last updated: August 11, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Pancreatic Cancer Drug: Oxaliplatin Radiation: SBRT Drug: Irinotecan Drug: Leucovorin Drug: 5FU Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

Estimated Enrollment: 172
Study Start Date: August 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926197

Contacts
Contact: Rachel Freiberg, PhD 650-725-0438 rachelf@stanford.edu
Contact: Amanda Simmons, MA 650-724-4606 amandals@stanford.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 60153
Contact: Jackie Hernandez    559-624-3015    JHernandez@mednet.ucla.edu   
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Rachel Freiberg    650-725-0438    rachelf@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, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Patrick Brooks    214-645-2250    Patrick.Brooks@UTSouthwestern.edu   
Canada, British Columbia
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Sonya Lam    604-877-6000 ext 6006    Sonya.Lam@bccancer.bc.ca   
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Sonca Lengoc    416-946-4501 ext 4820    sonca.lengoc@rmp.uhn.ca   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Daniel T Chang Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01926197     History of Changes
Other Study ID Numbers: PANC0015
27492
Study First Received: August 15, 2013
Last Updated: August 11, 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017