Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)
Not Applicable
Completed
- Conditions
- Melanoma, UvealUveal Melanoma
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- 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
- 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 Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale 3 years Measure of tumor scar thickness 3 years
Trial Locations
- Locations (1)
Institut Curie
🇫🇷Paris, France
Institut Curie🇫🇷Paris, France