FOLFIRINOX + RT for Pancreatic Cancer
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a therapy to learn whether the therapy works in treating a specific cancer. "Investigational" means that the therapy is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if therapy is effective for treating different types of cancer. Proton beam radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery system.
Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as it delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy, which tends to include more normal tissue along with tumor target tissue.
Researchers in the laboratory have discovered that there are pathways inside the cells that can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and capecitabine are targeted towards blocking the pathways that allow cancer cells to divide, and may result in the tumor shrinking in size.
In this research study, the investigators are looking to determine if proton beam radiation in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of your cancer.
|Pancreatic Cancer||Drug: FOLFIRINOX Drug: Capecitabine Radiation: Short Course Radiation Procedure: Surgery||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Preoperative FOLFIRINOX Followed by Accelerated Short Course Radiation Therapy for Borderline-Resectable Pancreatic Cancer|
- Rate of Resection [ Time Frame: 2 years ]To determine the rate of R0 resection of patients with borderline-resectable adenocarcinoma of the head of the pancreas, along with borderline-resectable and resectable adenocarcinoma of the body and tail of the pancreas
- Progression-Free Survival [ Time Frame: 2 years ]To determine the progression-free survival of patients who receive preoperative FOLFIRINOX and preoperative short-course radiation therapy
- Overall Survival [ Time Frame: 2 years ]To determine overall survival in patients treated with preoperative FOLFIRINOX and short course radiation therapy
- Toxicity rate [ Time Frame: 2 years ]To determine the frequency and severity of toxicities of FOLFIRINOX+short course radiation therapy in patients with pancreatic cancer
- Surgical Morbidity [ Time Frame: 2 years ]To determine the surgical morbidity in patients undergoing pancreaticoduodenectomy or distal pancreatectomy who received preoperative FOLFIRINOX and preoperative short course radiation therapy
- 30 Day Post-operative Mortality [ Time Frame: 2 years ]To determine 30 day post-operative mortality after pancreaticoduodenectomy or distal pancreatectomy in patients who receive preoperative FOLFIRINOX and short course radiation therapy
- Rate of Pathologic Downstaging [ Time Frame: 2 years ]To determine the rate of pathologic down-staging of FOLFIRINOX+short course radiation therapy for patients with pancreatic cancer
- Local Control Rates [ Time Frame: 2 years ]To determine local control rates with FOLFIRINOX+preoperative short course radiation therapy
- Correlation of Mutational Analysis Biomarkers [ Time Frame: 2 years ]To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment
|Actual Study Start Date:||May 2012|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.
Up to Eight-14 day cycles
Other Names:Drug: Capecitabine
Orally, for 10 daysRadiation: Short Course Radiation
Five or ten daysProcedure: Surgery
1-4 weeks after completion of capecitabine therapy
For weeks 1-8, you will only be receiving FOLFIRINOX via IV infusion. The treatment plan will begin with four cycles (8 weeks) of FOLFIRINOX. Each cycle is 14 days long. You will receive FOLFIRINOX therapy on days 1, 2 and 3 of each of the four cycles. The FOLFIRINOX treatment is broken up into three different drugs. 5-FU will be administered over two hours on day one of each cycle, and then continuously with a pump for days 2 and 3. Oxaliplatin will be delivered by intravenous (infusion) over 120 minutes. Irinotecan will be given by IV for 90 minutes. All parts of this treatment will be received as an outpatient.
If after 4 cycles of FOLFIRINOX therapy, your tumor has not spread, you will receive a further 4 cycles of FOLFIRINOX. If after 8 total cycles of FOLFIRINOX your cancer is clearly resectable, you will proceed to phase 2 of treatment with capecitabine and radiation therapy.
You will take tablets of capecitabine by mouth for a total of 10 days (Monday through Friday) during the two weeks after your FOLFIRINOX treatment.
You will be given a drug diary for capecitabine which contains instructions on how to take the drug.
Short course radiation: You will receive proton radiation treatment for five days (Monday through Friday) after your FOLFIRINOX treatment, during the time of your capecitabine treatment, or photon radiation for ten days (Monday through Friday for two weeks). You will also be assessed at least once during this treatment course for any side effects you may be experiencing.
You will receive study radiation treatment as an outpatient at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at the Massachusetts General Hospital Surgery is expected to occur approximately one to four weeks after completion of capecitabine therapy.
After your surgery, you may receive additional chemotherapy at the discretion of your treating physician and be followed as per standard of care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591733
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Theodore S Hong, M.D.||Massachusetts General Hospital|