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Completed

NCT Number: NCT02874040

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie

Paris, 75005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoresection

Procedure

Endoresection of the tumor scar

Laser diode

Procedure

Transpupillary thermotherapy by laser diode on the tumor scar

Other names: Thermotherapy

Primary outcomes

  1. Post-treatment complication incidence.

    Time frame: 3 years

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

Secondary outcomes

  1. Measure of tumor scar thickness

    Time frame: 3 years

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2023
Study completion
2024
First posted
Aug 22, 2016
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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