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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Institut Curie
Sponsor:
Information provided by (Responsible Party):
Institut Curie
ClinicalTrials.gov Identifier:
NCT02874040
First received: August 11, 2016
Last updated: August 16, 2016
Last verified: August 2016
  Purpose
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 Intervention Phase
Uveal Melanoma
Melanoma, Uveal
Procedure: Endoresection
Procedure: Laser diode
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut Curie:

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

Estimated Enrollment: 90
Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02874040     History of Changes
Other Study ID Numbers: IC 2012-03
Study First Received: August 11, 2016
Last Updated: August 16, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on March 24, 2017