Clinical trial NCT01926197: Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
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: A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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 criteria: INCLUSION CRITERIA

* Histologically-confirmed adenocarcinoma of the pancreas
* 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

* Metastatic disease
* 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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 38 months
Secondary outcomes:
measure: Local Progression-free Survival (Local PFS)
timeFrame: 38 months
measure: Progression-free Survival (PFS) at 1 Year
timeFrame: 1 year
measure: Metastasis-free Survival (MFS)
timeFrame: 62 months
measure: Overall Survival (OS)
timeFrame: 62 months
measure: Grade 2 or Greater Gastrointestinal (GI) Toxicity
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Stanford University
name: Daniel T Chang
role: PRINCIPAL_INVESTIGATOR
References: