Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients With Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT01821612|
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer||Drug: oxaliplatin Drug: irinotecan Drug: leucovorin Drug: 5-fluorouracil Drug: capecitabine Radiation: radiation Procedure: surgery Drug: gemcitabine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 5, 2014|
|Actual Study Completion Date :||June 15, 2018|
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
- 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 ]
- 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 ]
- Rate of treatment delay (greater than 4 weeks) during preoperative therapy [ Time Frame: Up to 28 weeks ]
- Completion rate of all preoperative and operative therapy [ Time Frame: Up to 30 weeks ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Overall survival [ Time Frame: From the date of registration to the date of the death due to all causes, assessed up to 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|