Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Oxaliplatin Type: Drug
Name: SBRT Type: Radiation
Name: Irinotecan Type: Drug
Name: Leucovorin Type: Drug
Name: 5FU Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the pancreas.

- Induction mFolfirinox up to 4 cycles.

- 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

- Acceptable organ and marrow function (as defined in Section 3.1).

- 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
Locations
UCLA
Los Angeles, California, United States
Status: Recruiting
Contact: Jackie Hernandez - 559-624-3015 - JHernandez@mednet.ucla.edu
Stanford University Cancer Institute
Stanford, California, United States
Status: Recruiting
Contact: Rachel Freiberg - 650-725-0438 - rachelf@stanford.edu
Loyola University
Maywood, Illinois, United States
Status: Recruiting
Contact: Beth Chiappetta, RN - 708-216-2568 - BCHIAPPETTA@lumc.edu
BC Cancer Agency
Vancouver, British Columbia, Canada
Status: Recruiting
Contact: Sunshine Purificacion - : 604-877-6000 - Sunshine.Purificacion@bccancer.bc.ca
Start Date
August 2013
Sponsors
Stanford University
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page