Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients With Pancreatic Cancer
Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: gemcitabine hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients With Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot Study|
- Accrual rate, calculated by total number of patients accrued divided by number of months from the date the study is opened at the fifth site to the evaluation date [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Rate of treatment-related toxicity during preoperative therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
- Rate of treatment delay (greater than 4 weeks) during preoperative therapy [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: Yes ]
- Completion rate of all preoperative and operative therapy [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]
- Macroscopic (R0/R1) resection rate defined as number of patients achieved R0 or R1 resection during surgery divided by number of evaluable patients [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
- Radiographic response rate defined as number of patients who achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during pre-operative therapy divided by the number of evaluable patients [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
- Histopathologic response rate defined as number of patients who achieved CR or PR determined according to histopathologic examination during pre-operative therapy divided by the number of evaluable patients [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
- Time to locoregional recurrence [ Time Frame: From the date of registration to the date of the first documented locoregional recurrence, assessed up to 3 years ] [ Designated as safety issue: No ]
- Time to distant recurrence [ Time Frame: From the date of registration to the date of the first documented distant recurrence, assessed up to 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From the date of registration to the date of the death due to all causes, assessed up to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Primary Completion Date:||July 2020 (Final data collection date for primary outcome measure)|
Experimental: mFOLFIRINOX, chemoradiation, surgery and gemcitabine
INDUCTION THERAPY: Patients receive mFOLFIRINOX chemotherapy comprising oxaliplatin IV over 2 hours on day 1, irinotecan hydrochloride IV over 90 minutes on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIATION: Beginning 2-6 weeks after completion of induction therapy, patients receive capecitabine PO BID 5 days a week and undergo 3-D conformal or intensity-modulated radiation therapy 5 days a week for 4 weeks.
SURGERY: Patients undergo pancreaticoduodenectomy within 4-10 weeks of completing chemoradiation.
ADJUVANT CHEMOTHERAPY: Beginning 6-8 weeks after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
IVDrug: irinotecan hydrochloride
IVDrug: leucovorin calcium
PORadiation: radiation Procedure: surgery
pancreaticoduodenectomyDrug: gemcitabine hydrochloride
The purpose of this study is to evaluate a new treatment program for patients with borderline resectable pancreas cancer in order to determine what effects, good and bad, chemotherapy and chemoradiation have on your cancer and to see if it allows safe surgery.
- To assess the accrual rate of this study.
- To assess the rate of treatment-related toxicity and treatment delay during preoperative therapy.
- To assess the rate of completion of all preoperative and operative therapy.
- To assess the macroscopic (R0/R1) resection rate.
- To estimate the rate of radiographic and histopathologic response to preoperative therapy.
- To estimate the time to locoregional and distant recurrence.
- To assess overall survival (OS).
- To retrieve nucleic acids from pretreatment pancreatic ductal adenocarcinoma biopsies and to assess the quality of these nucleic acids using a sequencing-based assessment of tumor DNA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821612
|United States, California|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|NorthShore University HealthSystem-Evanston Hospital|
|Evanston, Illinois, United States, 60201|
|United States, Kentucky|
|The James Graham Brown Cancer Center at University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Louisiana|
|Ochsner Medical Center Jefferson|
|New Orleans, Louisiana, United States, 70121|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|West Chester, Ohio, United States, 45069|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Matthew Katz, M.D.||M.D. Anderson Cancer Center|