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
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
Study Type
Interventional
Primary Outcome
Post-treatment complication incidence.
Secondary Outcome
Measure of tumor scar thickness
Condition
Uveal Melanoma
Intervention
Endoresection
Study Arms / Comparison Groups
Experimental
Description: endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar
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
Procedure
Estimated Enrollment
90
Start Date
April 19, 2013
Completion Date
September 2024
Primary Completion Date
May 2020
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nathalie CASSOUX, MD, PhD, , [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02874040
Organization ID
IC 2012-03
Responsible Party
Sponsor
Study Sponsor
Institut Curie
Study Sponsor
Nathalie CASSOUX, MD, PhD, Study Director, Institut Curie
Verification Date
March 2020