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New proton therapy aims to save eyes from removal in large melanoma cases

NCT ID NCT02602756

Disease control Sponsor: Centre Antoine Lacassagne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different proton therapy schedules for people with large choroidal melanomas (eye cancer) that would normally require removal of the eye. The goal was to see if a gentler radiation schedule could control the tumor and avoid severe side effects, allowing patients to keep their eye. The trial was stopped early, but it aimed to improve quality of life by offering a less drastic treatment option.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

32 people

The number who actually took part.

Started

Nov 2015

Finished

Nov 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient diagnosed with choroidal melanoma by an ophthalmologist and proton-therapy treatment proposed by the multi-disciplinary board meeting * Patient over 18 years old, male or female * Performance status ≤ 2 * Size and/or thickness greater than those proposed on proton-therapy appendix indications (tumor volume/ocular globe \> 40% and/or thickness ≥ 12 mm and/or diameter ≥ 18 mm or thickness ≥ 10 mm and diameter ≥ 15 mm). Possible ophthalmological follow-up examinations at 6 months, one year, 18 months and two years. * No contraindication for adjuvant chemotherapy * Authorized technique to preserve the optic nerve * Patient having undergone the required medical procedures: * Ophthalmological examination * Clip positioning * Proton-therapy treatment (localization CT, first simulation, second simulation, final simulation) * Patient reads information note and signs consent form Exclusion Criteria: * Exclusive iris damage * Exclusive conjunctival damage * First melanoma surgery * Enucleation planned post-proton-therapy * Exentration indication * Life expectancy \< 2 years * Scleral exteriorisation \> 2 mm * Absolute radiotherapy contraindication (ataxia-telangiectasia) * Cancer history, except for complete remission cancers of over 5 years, basocellular skin carcinomas completely resected, in-situ carcinomas or treated in situ cervical epithelioma * Presence of metastases other than hepatic (endoresection authorized)

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Conditions

The condition(s) this trial relates to.

malignant choroid melanoma melanoma Uveal Melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, 06000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.