NCT02843386

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

Randomized Phase III Study Comparing an Adjuvant Chemotherapy With Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

High risk uveal melanoma is defined by : * Clinical criteria: Largest Tumor Diameter ≥ 15 mm with extra scleral extension and/or retinal detachment or Largest Tumor Diameter ≥ 18 mm AND/ OR * Genomic high risk signature (aCGH +/-LOH): Monosomy 3 or partial deletion of 3p associated with any 8 gain. Treatment schedule : * Induction: Fotemustin 100 mg/m², D1-D8-D15, 1 hour IV infusion, 1 cycle * Maintenance : restart on D50, Fotemustine : 100 mg/m², 1 hour IV infusion, D1 D21, 5 cycles. Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival. Note :Based on the second interim analysis showing futility, and no chance to observe any significant statistical difference at the end of the study, the Independent Data Monitoring Committee recommended to stop randomization and amend the protocol to propose an interventional surveillance to high-risk patients as per protocol (April 2016).

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	Adjuvant chemotherapy by Fotemustin	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.
OTHER	Intensive surveillance	Intensive surveillance * Total duration: 3 years. * liver functional tests/3 months, - liver MRI or CT-scan/6 months, - whole body CT-scan/12 months.

Timeline

• Start date: 2009-06-23
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2016-07-25
• Last updated: 2022-08-31

Locations

6 sites across 2 countries: France, Switzerland