Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
|ClinicalTrials.gov Identifier: NCT00275119|
Recruitment Status : Unknown
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 11, 2006
Last Update Posted : February 9, 2009
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, 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 chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: oxaliplatin Radiation: radiation therapy||Phase 2|
- Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.
- Determine the tolerability of this regimen, in both the short- and long-term, in these patients.
- Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefits of this regimen in these patients.
- Determine locoregional and metastatic progression-free survival of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
- Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy.
- Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables|
|Study Start Date :||November 2003|
- Progression-free survival
- Recurrence-free survival
- Overall survival
- Response rate
- Quality of life
- Clinical benefits
- Locoregional and metastatic progression-free survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275119
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Bordeaux, France, F-33000|
|Dijon, France, 21000|
|CHU de Grenoble - Hopital de la Tronche|
|Grenoble, France, F-38043|
|Hopital Saint - Louis|
|La Rochelle, France, 17000|
|Clinique Victor Hugo|
|Le Mans, France, F-72000|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13009|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Study Chair:||Laurence Moureau-Zabotto, MD||Institut Paoli-Calmettes|