Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	Other	FFCD-2000-01 EU-20542, FFCD-SFRO-2000-01, NCT00416507

Objectives

Primary

1. 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

1. Compare the toxicities of these regimens in these patients.
2. Compare the objective response (complete, partial, or stable) in patients treated with these regimens.
3. Compare the clinical benefit, in terms of general condition and weight maintenance in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

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

Patient Characteristics:

• 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

Expected Enrollment

A total of 190 patients will be accrued for this trial.

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.

Chauffert B, Mornex F, Bonnetain F, et al.: 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 19 (9): 1592-9, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Federation Francophone de Cancerologie Digestive

Francoise Mornex, MD, PhD, Protocol chair		Ph: 33-478-864-253 Email: francoise.mornex@chu-lyon.fr

Registry Information
Official Title		Non Resectable But Non Metastatic Adenocarcinoma of the Exocrine Pancreas Non Resecables. Randomised Phase III: Initial Radiochimiotherapy (5-FU, Cisplatine, 60 GY Radiotherapy) Followed by Gemcitabine Versus Gemcitabine Alone
Registered in ClinicalTrials.gov		NCT00416507
Date Submitted to PDQ		2005-09-14
Information Last Verified		2008-05-12