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Clinical Trial Summary

Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type

The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.


Clinical Trial Description

As the data in litterature does not provide the basis for well-argued statistical hypothesis, it is suggested to randomize 30 patients per arm. An IDMC will come to a decision after the inclusion of 10, 20 ans 40 patients on the efficacy and the toxicity profile and on whether to maintain the current clinical position, justifying randomisation . In order to take into account any possible effects of prior concomitant radiochemotherapy, patient will be stratified according to whether they have already undergone chemotherapy or radiochemotherapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01248299
Study type Interventional
Source Centre Oscar Lambret
Contact
Status Terminated
Phase Phase 2
Start date January 2011
Completion date January 2017

See also
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Withdrawn NCT02041819 - Neoadjuvant Chemotherapy of Nimotuzumab Plus Nab-Paclitaxel in Squamous Cell Carcinoma of Esophagus Phase 2
Completed NCT00165490 - Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer Phase 2