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

Institut Curie

Status: Active, not recruiting

Conditions: Melanoma, Uveal; Uveal Melanoma

Treatments: Procedure: Laser diode; Procedure: Endoresection

Study type: Interventional

Funder types: Other

Identifiers

NCT02874040

IC 2012-03

Details and patient eligibility

About

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

Enrollment: 87 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

Experimental

Experimental group

Description:

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

Treatment:

Procedure: Endoresection

Procedure: Laser diode