An interventional study of Protontherapy in Melanoma, sponsored by Centre Antoine Lacassagne. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Centre Antoine Lacassagne · Not applicable, Interventional, and Treatment
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).
A more fractioned proton-therapy treatment, with doses per fraction of 6.5 Gy rather than 13 Gy, can limit the rate and the severity of complications degrading the quality of life by complications (pain, diminished visual acuity) and treatments (intra-ocular injections...).
In this study, patients will receive a total dose of 52 Gy in four 13 Gy sessions for the standard arm and in eight 6.5 Gy sessions for the experimental arm.
The investigators expect an identical local control rate within 2 year's time with a decrease in rate and severity of severe complications due to adapted fractionation (eight sessions with lower doses instead of four fractions with very high doses as it is usually recommended in the guidelines for small to medium melanomas).
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 32 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Centre Antoine Lacassagne is the lead sponsor of 65 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient having undergone the required medical procedures:
Exclusion Criteria:
Protontherapy : 4 sessions of 13 Gy, total dosis 52 Gy
Radiation: Protontherapy
Protontherapy : 8 sessions of 6.5 Gy, total dosis 52 Gy
Radiation: Protontherapy
Proton-therapy consists in four consecutive sessions. The experimental arm consists in eight sessions. Irradiation is administered over two weeks, delivering a total dose of 60 Cobalt Gris Equivalent (CGE is the physical Gray dose multiplied by a biological factor of relative efficiency of 1.1 for protons compared to photons).
local control rate without severe complications 2 years after.
Time frame: up to 60 months
Enucleation rate
Time frame: up to 60 months
Tumoral transretinien endoresection by unplanned vitrectomy in inclusion (emergency procedure)
Time frame: up to 60 months
Number of months without metastases evaluation
Time frame: up to 60 months
Number of months of Specific global survival evaluation
Time frame: up to 60 months
Complications and toxicity evaluation (number of subjects with adverse events related to treatment)
Time frame: up to 60 months
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Centre Antoine Lacassagne