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Trial record 68 of 520 for:    melanoma phase III

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

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ClinicalTrials.gov Identifier: NCT02843386
Recruitment Status : Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : April 28, 2017
Sponsor:
Collaborators:
Servier
UNICANCER
Information provided by (Responsible Party):
Institut Curie

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.


Condition or disease Intervention/treatment Phase
Uveal Melanoma Drug: Adjuvant chemotherapy by Fotemustin Other: Intensive surveillance Phase 3

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).


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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
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 Name: Fotemustin

B : Surveillance
Intensive surveillance
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.
Other Name: Surveillance




Primary Outcome Measures :
  1. Metastasis-Free survival [ Time Frame: 3 years ]
    Time between patient randomization and metastases occurrence or death


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
    Time between patient randomization and death

  2. 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

  3. 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
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.


Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Institut Curie
Servier
UNICANCER
Investigators
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Principal Investigator: Sophie PIPERNO-NEUMANN, MD Institut Curie

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02843386     History of Changes
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
Keywords provided by Institut Curie:
Uveal melanoma
High risk of metastasis
Genomic high risk signature
Adjuvant chemotherapy
Additional relevant MeSH terms:
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Melanoma
Nevi and Melanomas
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases