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

November 30, 2023 updated by: Institut Curie

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75005
        • Institut Curie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar
Procedure: Endoresection
Endoresection of the tumor scar
Procedure: Laser diode
Transpupillary thermotherapy by laser diode on the tumor scar
Other Names:
  • Thermotherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Study Director: Nathalie CASSOUX, MD, PhD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2013

Primary Completion (Actual)

October 24, 2023

Study Completion (Estimated)

October 24, 2024

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimated)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2012-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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