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

NCT02843386 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2022-08-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • UNICANCER

    collaborator OTHER

  • Institut Curie

    lead OTHER

Principal Investigators

  • Sophie PIPERNO-NEUMANN, MD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02843386 on ClinicalTrials.gov