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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01926197
Recruitment Status : Active, not recruiting
First Posted : August 20, 2013
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE August 15, 2013
First Posted Date  ICMJE August 20, 2013
Last Update Posted Date January 22, 2021
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2013)
difference in progression-free survival between mFOLFIRINOX alone vs. mFOLFIRINOX and SBRT [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
Official Title  ICMJE A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Oxaliplatin
  • Radiation: SBRT
  • Drug: Irinotecan
  • Drug: Leucovorin
  • Drug: 5FU
Study Arms  ICMJE
  • Active Comparator: mFFX
    mFOLFIRINOX
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Irinotecan
    • Drug: Leucovorin
    • Drug: 5FU
  • Experimental: mFFX+SBRT
    mFOLFIRINOX + SBRT
    Interventions:
    • Drug: Oxaliplatin
    • Radiation: SBRT
    • Drug: Irinotecan
    • Drug: Leucovorin
    • Drug: 5FU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 10, 2019)
27
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2013)
172
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01926197
Other Study ID Numbers  ICMJE IRB-27492
PANC0015 ( Other Identifier: OnCore )
NCI-2013-01658 ( Other Identifier: NCI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel T Chang Stanford University
PRS Account Stanford University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP