Back to resultsEndoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)
Primary Purpose
Uveal Melanoma, Melanoma, Uveal
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endoresection
Laser diode
Sponsored by
About this trial
This is an interventional treatment trial for Uveal Melanoma
Eligibility Criteria
Inclusion Criteria:
- Tumor of 7 mm of thickness or more
- Patients treated by proton beam therapy
- Patients aged at least 18 years
- Patients clearly informed of the study, having received the letter of information and signed the consent
Exclusion Criteria:
- Massive extrascleral extension posterior to the equator
- Patients with metastasis at diagnosis.
- Patients with glaucoma before the radiation therapy
- Patients with opaque media preventing transpupillary thermotherapy
- Patients for whom follow up will be difficult due to geographical, social or psychological reasons
Sites / Locations
- Institut CurieRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar
Outcomes
Primary Outcome Measures
Post-treatment complication incidence.
observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.
Secondary Outcome Measures
Measure of tumor scar thickness
Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02874040
Brief Title
Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)
Official Title
Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2013 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma, Melanoma, Uveal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar
Intervention Type
Procedure
Intervention Name(s)
Endoresection
Intervention Description
Endoresection of the tumor scar
Intervention Type
Procedure
Intervention Name(s)
Laser diode
Other Intervention Name(s)
Thermotherapy
Intervention Description
Transpupillary thermotherapy by laser diode on the tumor scar
Primary Outcome Measure Information:
Title
Post-treatment complication incidence.
Description
observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Measure of tumor scar thickness
Time Frame
3 years
Title
Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tumor of 7 mm of thickness or more
Patients treated by proton beam therapy
Patients aged at least 18 years
Patients clearly informed of the study, having received the letter of information and signed the consent
Exclusion Criteria:
Massive extrascleral extension posterior to the equator
Patients with metastasis at diagnosis.
Patients with glaucoma before the radiation therapy
Patients with opaque media preventing transpupillary thermotherapy
Patients for whom follow up will be difficult due to geographical, social or psychological reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie CASSOUX, MD, PhD
Email
nathalie.cassoux@curie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed ABDELI
Phone
+ 33 (1)1 56 24 59 44
Email
ahmed.abdeli@curie.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie CASSOUX, MD, PhD
Organizational Affiliation
Institut Curie
Official's Role
Study Director
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Cassoux, MD, PhD
Phone
+ 33 (0)1 44 32 42 42
Email
nathalie.cassoux@curie.fr
First Name & Middle Initial & Last Name & Degree
Ezzili, Sc. PhD
First Name & Middle Initial & Last Name & Degree
Nathalie Cassoux, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)
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