Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT02602756
Status:
TERMINATED
Last Update Posted:
2022-12-14
First Post:
2015-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing Two Models of Hypofractionated Protontherapy on Large Choroidal Melanomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D000098943', 'term': 'Uveal Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study with 2 differents dosages of proton therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'insufficient quality of data collection', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local control rate without severe complications 2 years after.', 'timeFrame': 'up to 60 months'}], 'secondaryOutcomes': [{'measure': 'Enucleation rate', 'timeFrame': 'up to 60 months'}, {'measure': 'Tumoral transretinien endoresection by unplanned vitrectomy in inclusion (emergency procedure)', 'timeFrame': 'up to 60 months'}, {'measure': 'Number of months without metastases evaluation', 'timeFrame': 'up to 60 months'}, {'measure': 'Number of months of Specific global survival evaluation', 'timeFrame': 'up to 60 months'}, {'measure': 'Complications and toxicity evaluation (number of subjects with adverse events related to treatment)', 'timeFrame': 'up to 60 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Choroid Melanoma'], 'conditions': ['Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.centreantoinelacassagne.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nReferential 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.\n\nOur 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).', 'detailedDescription': "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...).\n\nIn 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.\n\nThe 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with choroidal melanoma by an ophthalmologist and proton-therapy treatment proposed by the multi-disciplinary board meeting\n* Patient over 18 years old, male or female\n* Performance status ≤ 2\n* 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.\n* No contraindication for adjuvant chemotherapy\n* Authorized technique to preserve the optic nerve\n* Patient having undergone the required medical procedures:\n\n * Ophthalmological examination\n * Clip positioning\n * Proton-therapy treatment (localization CT, first simulation, second simulation, final simulation)\n* Patient reads information note and signs consent form\n\nExclusion Criteria:\n\n* Exclusive iris damage\n* Exclusive conjunctival damage\n* First melanoma surgery\n* Enucleation planned post-proton-therapy\n* Exentration indication\n* Life expectancy \\< 2 years\n* Scleral exteriorisation \\> 2 mm\n* Absolute radiotherapy contraindication (ataxia-telangiectasia)\n* 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\n* Presence of metastases other than hepatic (endoresection authorized)'}, 'identificationModule': {'nctId': 'NCT02602756', 'acronym': 'HYGROMEL', 'briefTitle': 'Study Assessing Two Models of Hypofractionated Protontherapy on Large Choroidal Melanomas', 'organization': {'class': 'OTHER', 'fullName': 'Centre Antoine Lacassagne'}, 'officialTitle': 'Phase II Trial, Randomized, Under Single-blind Conditions, Assessing Two Models of Modified Hypofractionated Proton-therapy on Patients With Large Choroidal Melanomas', 'orgStudyIdInfo': {'id': '2015/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Protontherapy : 4 sessions of 13 Gy, total dosis 52 Gy', 'interventionNames': ['Radiation: Protontherapy']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Protontherapy : 8 sessions of 6.5 Gy, total dosis 52 Gy', 'interventionNames': ['Radiation: Protontherapy']}], 'interventions': [{'name': 'Protontherapy', 'type': 'RADIATION', 'description': '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).', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Juliette THARIAT, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Antoine Lacassagne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Antoine Lacassagne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}