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Prospectively Randomized Phase III Study of an Individualized Sensitivity-Directed Combination Chemotherapy Versus DTIC as First-Line Treatment in Stage IV Metastatic Melanoma (ChemoSensMM)

NCT00779714 Phase 3 UNKNOWN

This phase III trial is aimed to investigate the efficacy of an individualized, sensitivity-directed combination chemotherapy in comparison to the standard regimen DTIC. Two question are aimed to be answered by this study: 1. Is the individual chemosensitivity index (BICSI) a prognostic / predictive biomarker for chemotherapy ? 2. Is an individualized, sensitivity-directed combination chemotherapy superior to the standard regimen DTIC in terms of survival and response ?

Details

Lead sponsorUniversity of Wuerzburg
PhasePhase 3
StatusUNKNOWN
Enrolment360
Start date2008-10
Completion2013-04

Conditions

Interventions

Primary outcomes

Countries

Germany