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

Not Applicable

Active, not recruiting

• Conditions: Melanoma, Uveal; Uveal Melanoma
• Interventions: Procedure: Endoresection; Procedure: Laser diode

• Registration Number: NCT02874040
• Lead Sponsor: Institut Curie

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-19
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-22
• Primary Completion: 2023-10-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Study Completion: 2024-10-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 87

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Endoresection	endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar
Experimental	Laser diode	endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar

Primary Outcome Measures

Name	Time	Method
Post-treatment complication incidence.	3 years	observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.

Secondary Outcome Measures

Name	Time	Method
Measure of tumor scar thickness	3 years
Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale	3 years

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France