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

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Brief Title

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

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 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).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Metastasis-Free survival

Secondary Outcome

 Overall Survival

Condition

Uveal Melanoma

Intervention

Adjuvant chemotherapy by Fotemustin

Study Arms / Comparison Groups

 A : Chemotherapy
Description:  Adjuvant chemotherapy by Fotemustin 100mg/m²

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

302

Start Date

June 23, 2009

Completion Date

November 2020

Primary Completion Date

May 2020

Eligibility Criteria

        Inclusion Criteria:

          1. 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

          2. Age ≥ 18 years and ECOG Performance Status ≤ 2

          3. No prior chemotherapy or history of invasive cancer < 5years

          4. No metastases

          5. 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:

          1. 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.

          2. Contraindication to Fotemustine administration

          3. Hematological function : Hb < 10g/dL, absolute neutrophil count < 2,000/mm3, and
             platelets < 100,000/mm3

          4. Biochemistry results :Total bilirubin and AST/ALT > 1,5 UNL (Upper Normal Limit)

          5. Creatinine > 1,5 UNL (Upper Normal Limit)

          6. 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sophie PIPERNO-NEUMANN, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02843386

Organization ID

IC 2008-03


Responsible Party

Sponsor

Study Sponsor

Institut Curie

Collaborators

 Servier

Study Sponsor

Sophie PIPERNO-NEUMANN, MD, Principal Investigator, Institut Curie


Verification Date

April 2017