Comparison Between Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma (FOTEADJ)
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ClinicalTrials.gov Identifier: NCT02843386 |
Recruitment Status : Unknown
Verified April 2017 by Institut Curie.
Recruitment status was: Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : April 28, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uveal Melanoma | Drug: Adjuvant chemotherapy by Fotemustin Other: Intensive surveillance | Phase 3 |
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).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 302 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Phase III Study Comparing an Adjuvant Chemotherapy With Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma |
Actual Study Start Date : | June 23, 2009 |
Estimated Primary Completion Date : | May 2020 |
Estimated Study Completion Date : | November 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: A : Chemotherapy
Adjuvant chemotherapy by Fotemustin 100mg/m²
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Drug: Adjuvant chemotherapy by Fotemustin
Fotemustin is given for 6 cycles :
Other Name: Fotemustin |
B : Surveillance
Intensive surveillance
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Other: Intensive surveillance
Intensive surveillance
Other Name: Surveillance |
- Metastasis-Free survival [ Time Frame: 3 years ]Time between patient randomization and metastases occurrence or death
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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.
6 - Contraception in women of child-bearing potential
7- Written informed consent
8- Patients with French Social Security in compliance with the French law relating to biomedical research.
Non-Inclusion Criteria:
- 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)
- Pregnant and/or breastfeeding women.
8 - Previous history of cancer excepting in situ cervical carcinoma or cutaneous basal carcinoma.
7- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, viral or other hepatitis or cirrhosis, or psychiatric illness/social situation that would interfere with the protocol or limit compliance with study requirements.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843386
France | |
Centre Jean Perrin | |
Clermont-ferrand, France, 63011 | |
Centre Léon Bérard | |
Lyon, France, 69373 | |
CHU Nice | |
Nice, France, 06003 | |
Centre Antoine Lacassagne | |
Nice, France, 06189 | |
Institut Curie | |
Paris, France, 75005 | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, 1011 |
Principal Investigator: | Sophie PIPERNO-NEUMANN, MD | Institut Curie |
Responsible Party: | Institut Curie |
ClinicalTrials.gov Identifier: | NCT02843386 |
Other Study ID Numbers: |
IC 2008-03 |
First Posted: | July 25, 2016 Key Record Dates |
Last Update Posted: | April 28, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Uveal melanoma High risk of metastasis Genomic high risk signature Adjuvant chemotherapy |
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |