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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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).


Sponsor: Institut Curie

Current Primary Outcome: Metastasis-Free survival [ Time Frame: 3 years ]

Time between patient randomization and metastases occurrence or death


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Survival [ Time Frame: 3 years ]
    Time between patient randomization and death
  • Safety : incidence of Adverse Events and Serious Adverse Events and laboratory abnormalities [ Time Frame: 3 years ]
    using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) V3
  • Quality of life assessment [ Time Frame: Baseline, 6 months and 3 years ]
    Using QLQ-C30 questionary.


Original Secondary Outcome:

  • Overall Survival [ Time Frame: 3 years ]
    Time between patient randomization and death
  • Safety : incidence of Adverse Events and Serious Adverse Events and laboratory abnormalities [ Time Frame: 3 years ]
    using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) V3
  • Quality of life assessment [ Time Frame: 3 years ]
    At Baseline, 6 months, and 36 months. Using QLQ-C30 questionary.


Information By: Institut Curie

Dates:
Date Received: July 21, 2016
Date Started: June 23, 2009
Date Completion: November 2020
Last Updated: April 27, 2017
Last Verified: April 2017