Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02843386 | Comparison Between Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma | PHASE3 | COMPLETED | 302 | — | — | Jun 23, 2009 | Jun 12, 2020 | Aug 31, 2022 | 6 | France, Switzerland |
Time between patient randomization and metastases occurrence or death
| Arm | Type | Description |
|---|---|---|
| A : Chemotherapy | EXPERIMENTAL | Adjuvant chemotherapy by Fotemustin 100mg/m² |
| B : Surveillance | OTHER | Intensive surveillance |
| Name | Type | Description |
|---|---|---|
| Adjuvant chemotherapy by Fotemustin | DRUG | Fotemustin is given for 6 cycles : * One Induction cycle: Fotemustin 100 mg/m², 1 hour IV infusion, D1D8D15, 5 week rest period, restart on D50. * Five Maintenance cycles: Fotemustin 100 mg/m², 1 hour IV infusion, D1-D21. |
| Intensive surveillance | OTHER | Intensive surveillance * Total duration: 3 years. * liver functional tests/3 months, - liver MRI or CT-scan/6 months, - whole body CT-scan/12 months. |
Inclusion Criteria: 1. High risk uveal melanoma, defined by : * Clinical criteria: Largest Tumor Diameter ≥ 15 mm with extrascleral extension and/or retinal detachment or Largest Tumor Diameter ≥ 18 mm AND/OR * Genomic high risk signature (cCGH +/- LOH) : Monosomy 3 or partial deletion of 3p...