NCT02843386

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_3

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2009

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

11 years

First QC Date

July 21, 2016

Last Update Submit

August 30, 2022

Conditions

Uveal Melanoma

Keywords

Uveal melanomaHigh risk of metastasisGenomic high risk signatureAdjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Metastasis-Free survival

    Time between patient randomization and metastases occurrence or death

    3 years

Secondary Outcomes (3)

  • Overall Survival

    3 years

  • Safety : incidence of Adverse Events and Serious Adverse Events and laboratory abnormalities

    3 years

  • Quality of life assessment

    Baseline, 6 months and 3 years

Study Arms (2)

A : Chemotherapy

EXPERIMENTAL

Adjuvant chemotherapy by Fotemustin 100mg/m²

Drug: Adjuvant chemotherapy by Fotemustin

B : Surveillance

OTHER

Intensive surveillance

Other: Intensive surveillance

Interventions

Adjuvant chemotherapy by FotemustinDRUG

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.

Also known as: Fotemustin
A : Chemotherapy
Intensive surveillanceOTHER

Intensive surveillance * Total duration: 3 years. * liver functional tests/3 months, - liver MRI or CT-scan/6 months, - whole body CT-scan/12 months.

Also known as: Surveillance
B : Surveillance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 and any 8 gain, from enucleation, transscleral or transvitreal samples
  • Age ≥ 18 years and ECOG Performance Status ≤ 2
  • No prior chemotherapy or history of invasive cancer \< 5years
  • No metastases
  • Local treatment for the primary tumour (surgery and/or radiotherapy) achieved ≤ 30 days from randomization, chemotherapy to begin within 15 days.
  • Contraception in women of child-bearing potential
  • Written informed consent
  • Patients with French Social Security in compliance with the French law relating to biomedical research.
  • Largest Tumor Diameter \< 15 mm or Largest Tumor Diameter 15-18 mm without extrascleral extension and/or retinal detachment, in the absence of genomic alteration as defined per protocol or in the absence of Fine Needle Aspiration biopsy for genomic risk assessment.
  • Contraindication to Fotemustine administration
  • Hematological function : Hb \< 10g/dL, absolute neutrophil count \< 2,000/mm3, and platelets \< 100,000/mm3
  • Biochemistry results :Total bilirubin and AST/ALT \> 1,5 UNL (Upper Normal Limit)
  • Creatinine \> 1,5 UNL (Upper Normal Limit)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

CHU Nice

Nice, 06003, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Paris, 75005, France

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Study Officials

  • Sophie PIPERNO-NEUMANN, MD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 25, 2016

Study Start

June 23, 2009

Primary Completion

June 12, 2020

Study Completion

June 12, 2020

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)CH(1)