Gemcitabine With Or Without Combination Chemotherapy And Radiation Therapy In Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Study Overview

Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for pancreatic cancer. PURPOSE: This randomized phase III trial is studying gemcitabine, fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine alone in treating patients with nonmetastatic pancreatic cancer that cannot be removed by surgery.

OBJECTIVES: Primary * Compare the overall survival of patients with nonresectable, nonmetastatic adenocarcinoma of the pancreas treated with gemcitabine hydrochloride with vs without fluorouracil, cisplatin, and radiotherapy followed by gemcitabine hydrochloride. Secondary * Compare the toxicities of these regimens in these patients. * Compare the objective response (complete, partial, or stable) in patients treated with these regimens. * Compare the clinical benefit, in terms of general condition and weight maintenance in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 or 1 vs 2), initial treatment (laparotomy with or without bilio-digestive diversion) (yes vs no), and peritoneal cytology (positive vs negative). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive cisplatin IV over 15 minutes on days 1-5 and 29-33 and fluorouracil IV continuously on days 1-40. Patients also undergo radiotherapy daily, 5 days a week, for 6 weeks. * Arm II: Patients receive gemcitabine hydrochloride IV over 15 minutes on day 1. Treatment repeats every 7 days for 7 weeks. Beginning in week 11 of arm I or week 9 of arm II, patients receive gemcitabine hydrochloride IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically. PROJECTED ACCRUAL: A total of 190 patients will be accrued for this trial.

Pancreatic Cancer

DRUG: fluorouracil
DRUG: gemcitabine hydrochloride
DRUG: liposomal cisplatin

CDR0000453847
FFCD-2000-01
EU-20542
FFCD-SFRO-2000-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-12-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-05-27
First Submitted that Met QC Criteria 2006-12-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-05-30
First Posted (ESTIMATED) 2006-12-28	Results First Posted N/A	Last Verified 2016-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

Histologically or cytologically confirmed adenocarcinoma of the pancreas
No neuroendocrine or other histologies
No extra-abdominal metastases
No hepatic or peritoneal metastases by celioscopy

Peritoneal carcinomatous (cytology positive by peritoneal lavage) may be allowed
Nonresectable disease meeting ≥ 1 of the following criteria:

Arterial invasion
Mesenteric-portal vein invasion > 15 mm and or less than hemicircumference
Satellite adenopathies encompassed in the radiation field

WHO performance status 0-2
Bilirubin < 1.75 mg/dL
Creatinine < 1.5 mg/dL
WBC > 1,500/mm³
Platelet count > 100,000/mm³
No major organ disorder, including cardiac or coronary insufficiency
Prothrombin time > 80%
No psychiatric or social condition that would preclude study therapy
No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
No contraindications to radiotherapy or chemotherapy
No intractable pancreatic pain not relieved by morphine and/or analgesic radiotherapy

No prior adjuvant or palliative chemotherapy or radiotherapy
Prior surgical diversion of the biliary and/or digestive tract allowed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Francoise Mornex, MD, PhD, Centre Hospitalier Lyon Sud

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Chauffert B, Mornex F, Bonnetain F, Rougier P, Mariette C, Bouche O, Bosset JF, Aparicio T, Mineur L, Azzedine A, Hammel P, Butel J, Stremsdoerfer N, Maingon P, Bedenne L. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study. Ann Oncol. 2008 Sep;19(9):1592-9. doi: 10.1093/annonc/mdn281. Epub 2008 May 7.
Mornex F, Chauffert B, Bonnetain F, et al.: Definitive results of the French FFCD-SFRO 2000-01 study: phase III trial comparing chemoradiotherapy (cisplatin and infusional 5-FU) followed by gemcitabine vs. gemcitabine alone in patients with locally advanced non metastatic pancreatic cancer. [Abstract] Int J Radiat Oncol Biol Phys 69 (3): A-135, S77, 2007.

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