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NCT02874040 Clinical Trial

Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)

Uveal Melanoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02874040
Other study ID # IC 2012-03
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 19, 2013
Est. completion date October 24, 2024

Study information
Verified date November 2023
Source Institut Curie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 87
Est. completion date October 24, 2024
Est. primary completion date October 24, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoresection
Endoresection of the tumor scar
• Laser diode
Transpupillary thermotherapy by laser diode on the tumor scar

Locations
Country Name City State
France Institut Curie Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-treatment complication incidence. observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations. 3 years
Secondary Measure of tumor scar thickness 3 years
Secondary Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale 3 years
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