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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)
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 sponsor | University of Wuerzburg |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 360 |
| Start date | 2008-10 |
| Completion | 2013-04 |
Conditions
- Melanoma
Interventions
- DTIC (dacarbazine)
- paclitaxel + cisplatin
- treosulfan + cytarabine
Primary outcomes
- Disease-specific overall survival — 4 years
Countries
Germany