Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT00160030|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 7, 2009
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 or disease||Intervention/treatment||Phase|
|Esophageal Neoplasms||Drug: FOLFOX 4 Drug: 5-FU / Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||October 2007|
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.
|Active Comparator: 2||
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).
- Percentage of patients having completed the full treatment and Endoscopic complete response rate [ Time Frame: at the end of the study ]
- Toxicity profile (NCI-CTC). [ Time Frame: evaluated each week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160030
|Study Director:||Marie SEBILLE||Sanofi|