Uveal MelanomaNCT02874040
Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)
A study testing Endoresection and Laser diode in people with Uveal Melanoma and Melanoma, Uveal, run by Institut Curie at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uveal Melanoma, Melanoma, Uveal
- What is being tested?
- Endoresection and Laser diode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2013to 24 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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 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
- Conditions
- Uveal Melanoma, Melanoma, Uveal
- Being tested
- Endoresection, Laser diode
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoresectionProcedure or surgery
Endoresection of the tumor scar
Laser diodeProcedure or surgery
Also called Thermotherapy
Transpupillary thermotherapy by laser diode on the tumor scar
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar Receives: Procedure: Endoresection; Procedure: Laser diode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment complication incidence.
observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.
Measured: 3 years
Secondary outcomes (2)
Measure of tumor scar thickness
Measured: 3 years
Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start19 Apr 2013
- Primary completion24 Oct 2023
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie CASSOUX, MD, PhD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874040
- Sponsor's protocol ID
- IC 2012-03
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2016
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02874040
- Acronym / sponsor ID
- IC 2012-03
- Conditions
- Uveal Melanoma, Melanoma, Uveal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 19 Apr 2013 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Endoresection, Procedure: Laser diodeendoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoresectionEndoresection of the tumor scar | Procedure or surgery | Experimental |
| Laser diodeAlso: ThermotherapyTranspupillary thermotherapy by laser diode on the tumor scar | Procedure or surgery | Experimental |
Primary outcome
Post-treatment complication incidence.
Time frame: 3 years
observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie CASSOUX, MD, PhD study director
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoresection and Laser diode in people with Uveal Melanoma and Melanoma, Uveal, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment complication incidence. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.