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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 (Endoresection-Laser)

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ClinicalTrials.gov Identifier: NCT02874040
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Uveal Melanoma Melanoma, Uveal Procedure: Endoresection Procedure: Laser diode Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2013
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2018


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 Name: Thermotherapy




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874040


Contacts
Contact: François Doz, MD, PhD + 33 (0)1 44 32 45 50 francois.doz@curie.fr
Contact: Souhir Neffati + 33 (1)1 56 24 59 44 souhir.neffati@curie.fr

Locations
France
Institut Curie Recruiting
Paris, France, 75005
Contact: Nathalie Cassoux, MD, PhD    + 33 (0)1 44 32 42 42    nathalie.cassoux@curie.fr   
Contact: Cyrine Ezzili, Sc. PhD    + 33 (0)1 56 24 56 48    cyrine.ezzili@curie.fr   
Principal Investigator: Nathalie Cassoux, MD, PhD         
Sponsors and Collaborators
Institut Curie
Investigators
Study Director: Laurence Desjardins, MD, PhD Institut Curie

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02874040     History of Changes
Other Study ID Numbers: IC 2012-03
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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