Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
|ClinicalTrials.gov Identifier: NCT00112697|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 3, 2005
Last Update Posted : November 2, 2011
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, 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. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.
PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: cisplatin Drug: docetaxel Drug: fluorouracil Radiation: radiation therapy||Phase 2|
- Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy.
- Compare the toxicity of these regimens in these patients.
- Compare the objective response rate in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks.
- Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks.
In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Official Title:||Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients|
|Study Start Date :||December 2002|
- Progression-free survival rate at 6 months
- Objective response rate
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112697
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Polyclinique des Quatre Pavillons|
|Lormont, France, 33310|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Centre Rene Huguenin|
|Saint Cloud, France, 92210|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Michel Ducreux, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|