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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416507
First received: December 27, 2006
Last updated: January 22, 2011
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: liposomal cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 190
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

PRIOR CONCURRENT THERAPY:

  • No prior adjuvant or palliative chemotherapy or radiotherapy
  • Prior surgical diversion of the biliary and/or digestive tract allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416507

Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Study Chair: Francoise Mornex, MD, PhD Centre Hospitalier Lyon Sud
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00416507     History of Changes
Other Study ID Numbers: CDR0000453847, FFCD-2000-01, EU-20542, FFCD-SFRO-2000-01
Study First Received: December 27, 2006
Last Updated: January 22, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage III pancreatic cancer
stage II pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014