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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00160030 |
The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms.
The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).
Condition | Intervention | Phase |
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Esophageal Neoplasms |
Drug: FOLFOX 4 Drug: 5-FU / Cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study Comparing Radiochemotherapy With the Folfox 4 Regimen Versus Radiochemotherapy With 5FU-Cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Esophageal Cancer |
Enrollment: | 97 |
Study Start Date: | September 2004 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: FOLFOX 4
total treatment of six 2-weekly cycles of FOLFOX 4, the first 3 cycles starting on D1, D15 and D29 concomitant with 5 weeks' radiotherapy.
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2: Active Comparator |
Drug: 5-FU / Cisplatin
two cycles of 5-FU / Cisplatin on week 1 and 5 of radiotherapy and two cycles of chemotherapy with 5-FU / Cisplatin on week 8 and 11 (one cycle each three weeks after the end of radiotherapy).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with:
Adequate bone marrow reserve, normal renal and liver functions:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | L_9326 |
Study First Received: | September 9, 2005 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00160030 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Digestive System Neoplasms Digestive System Diseases Cisplatin Esophageal disorder Gastrointestinal Diseases Fluorouracil |
Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Esophageal neoplasm |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |