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

NCT02874040 | Completed

• 1 other identifier: IC 2012-03
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Conditions

Uveal Melanoma; Melanoma, Uveal

Outcome Measures

Primary Outcomes (1)

• Post-treatment complication incidence.

  observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.

  3 years

Secondary Outcomes (2)

• Measure of tumor scar thickness

  3 years

• Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale

  3 years

Study Arms (1)

Experimental

EXPERIMENTAL

endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar

Procedure: Endoresection; Procedure: Laser diode

Interventions

Endoresection PROCEDURE

Endoresection of the tumor scar

Experimental

Laser diode PROCEDURE

Transpupillary thermotherapy by laser diode on the tumor scar

Also known as: Thermotherapy

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Lasers, Semiconductor; Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Therapeutics

Study Officials

• Nathalie CASSOUX, MD, PhD

  Institut Curie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 22, 2016
• Study Start: April 19, 2013
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)