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

Brief Title

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

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

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
    

Study Type

Interventional

Primary Outcome

Post-treatment complication incidence.

Secondary Outcome

 Measure of tumor scar thickness

Condition

Uveal Melanoma

Intervention

Endoresection

Study Arms / Comparison Groups

 Experimental

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

90

Start Date

April 19, 2013

Completion Date

September 2024

Primary Completion Date

May 2020

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nathalie CASSOUX, MD, PhD, , [email protected]

Location Countries

France

Location Countries

France

NCT ID

NCT02874040

Organization ID

IC 2012-03

Responsible Party

Sponsor

Study Sponsor

Institut Curie

Study Sponsor

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

Verification Date

March 2020