drugset / Trial / NCT02843386

Comparison Between Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma

NCT02843386 ↗

Phase 3 Completed 302 enrolled Institut Curie Servier · collabUNICANCER · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external radiotherapy) patients with high risk of metastasis are randomized between: * Adjuvant chemotherapy with Fotemustin. * Observation Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.

Timeline

Start
2009-06-23
Primary completion
2020-06-12
Completion
2020-06-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Fotemustin Unknown 100 mg/m2 Intravenous

Indications