Study Assessing Two Models of Hypofractionated Protontherapy on Large Choroidal Melanomas (NCT02602756) | Clinical Trial Compass
TerminatedNot Applicable
Study Assessing Two Models of Hypofractionated Protontherapy on Large Choroidal Melanomas
Stopped: insufficient quality of data collection
France32 participantsStarted 2015-11-02
Plain-language summary
Ocular melanomas have been treated for a long time by enucleation, with an unfavorable major impact on the patient's quality of life, social life, self-image, how they feel about others and about living with this disability. As a matter of fact, classical radiation therapy by photons is not accurate enough to deliver a sufficiently high dose to eradicate a melanoma without causing irreversible ocular brain complications since these tumors are " relatively radio resistant ". The possibility of delivering high doses due to the precision of protons ("Bragg peak") has allowed to overcome this limitation. The conservative uveal melanoma treatment has become a standard after the Collaborative Ocular Melanoma Study (COMS) indicating an equivalent rate of metastases and a non-impaired survival rate with a conservative treatment when compared to immediate enucleation. The quality of life benefits due to a conservative treatment has been demonstrated. Protontherapy dose has been defined in an empirical manner, it is probably excessive even if it applies to radio-resistant tumors. In France, radiotherapy by protons for choroidal melanomas delivers a dose of 60 Gy cobalt equivalent (that is 52 measured Gy, or " Physical dose") in 4 fractions and 4 days.
Referential treatment of ocular melanomas (other than conjunctiva) indicates proton-therapy for T1, T2, T3 \< 40% of ocular volume, and T4 only if extra scleral extension ≤ 2mm. However, there is an enucleation indication for T3 \> 40% of ocular volume and T4.
Our purpose is to override this relative contraindication, choroidal melanoma volume ≥ 40% of ocular volume. As a matter of fact, the investigators observe an increasing demand from ophthalmologists and patients for not performing primary enucleation. Also, during the last five years treatment of complications have improved and a less " hard " hypo fractionation (6.5 Gy per fraction) has equivalent local control results as for " hard " fractionation (13 Gy per fraction).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether the treatment approach it was testing is still considered safe or promising for my situation?
2Since this study was specifically for large choroidal melanomas, how does the size of my tumor compare to what this trial was targeting, and does that change which treatment options make the most sense for me?
3The trial was comparing two schedules of proton therapy — what do we currently know about hypofractionated proton therapy for choroidal melanoma based on whatever data was collected before the trial ended?
4Given that this trial was terminated and may not have reached its goal of measuring local control at two years, are there other completed studies or standard proton therapy protocols I should be asking about instead?
5How does proton therapy in general compare to other treatments like plaque brachytherapy or enucleation for large choroidal melanomas, and would one of those be a more established path for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
local control rate without severe complications 2 years after.