Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
NCT ID: NCT01926197
Last Updated: 2022-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
27 participants
INTERVENTIONAL
2013-08-14
2022-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modified FOLFIRINOX
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
Oxaliplatin
Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
Irinotecan
Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
Leucovorin
Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
5FU
5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
Oxaliplatin
Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
Irinotecan
Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
Leucovorin
Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
5FU
5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
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.
Interventions
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Oxaliplatin
Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
Irinotecan
Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
Leucovorin
Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
5FU
5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board.
* Stable or better disease on re-staging scans
* Typically, tumors \< 8.0 cm in greatest axial dimension but final determination of eligibility based upon radiation normal tissue constraints
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
* Leukocytes (white blood cells, WBC) ≥ 3,000/mL
* Absolute neutrophil count (ANC) ≥ 1,500/mL
* Platelets ≥ 50,000/mL
* Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 X institutional ULN
* Creatinine within normal institutional limits
* Ability to understand and the willingness to sign an informed consent form
* Life expectancy \> 6 months
Exclusion Criteria
* Prior radiotherapy to the upper abdomen/liver.
* Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified FOLFIRINOX.
* Age \< 18 years
* 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
* 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 or lactating
* 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) for duration of the study
* 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
* Male subjects who are unwilling or unable to use effective contraception for duration of the study
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Lucas Kas Vitzthum
Clinical Assistant Professor
Principal Investigators
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Daniel T Chang
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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UCLA
Los Angeles, California, United States
UCSF
San Francisco, California, United States
Stanford University, School of Medicine
Stanford, California, United States
Loyola University
Maywood, Illinois, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
BC Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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PANC0015
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2013-01658
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-27492
Identifier Type: -
Identifier Source: org_study_id
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