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Clinical Trial Summary

This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes.


Clinical Trial Description

This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes. Patients - will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study"). - will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment). The primary objective is to evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04016142
Study type Interventional
Source Centre Oscar Lambret
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 15, 2020
Completion date August 2025

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