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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01926197|
Recruitment Status : Recruiting
First Posted : August 20, 2013
Last Update Posted : March 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Oxaliplatin Radiation: SBRT Drug: Irinotecan Drug: Leucovorin Drug: 5FU||Phase 3|
A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial
To determine progression free survival for mFFX +/- SBRT.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2019|
Active Comparator: mFFX
|Drug: Oxaliplatin Drug: Irinotecan Drug: Leucovorin Drug: 5FU|
mFOLFIRINOX + SBRT
|Drug: Oxaliplatin Radiation: SBRT Drug: Irinotecan Drug: Leucovorin Drug: 5FU|
- difference in progression-free survival between mFOLFIRINOX alone vs. mFOLFIRINOX and SBRT [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926197
|Contact: Samantha Wongfirstname.lastname@example.org|
|United States, California|
|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: Samantha Wong 650-498-8495 email@example.com|
|Principal Investigator: Daniel T Chang|
|United States, Illinois|
|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|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Sonca Lengoc 416-946-4501 ext 4820 firstname.lastname@example.org|
|Principal Investigator:||Daniel T Chang||Stanford University|