Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02602756 : Study Assessing Two Models of Hypofractionated Protontherapy on Large Choroidal Melanomas
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
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)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02602756      |      Link to official Clinicaltrials.gov listing
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