Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT03637335
Status:
TERMINATED
Last Update Posted:
2018-08-20
First Post:
2018-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Palliative Radiotherapy With or Without Carboplatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011827', 'term': 'Radiation'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase-3 study, randomized, controlled, multi-center, double blind'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'The study was stopped due to insufficient recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy', 'timeFrame': '36 months', 'description': '= delay between the start date of treatment and the date of the first event related to the treated location'}], 'secondaryOutcomes': [{'measure': 'Impact in quality of life', 'timeFrame': '25 months', 'description': 'Evaluate with questionnaire QLQ-C30 at inclusion, at the end of treatment and during the following'}, {'measure': 'Variation in intensity of pain', 'timeFrame': '25 months', 'description': 'Analogical visual scale (EVA)'}, {'measure': 'evolution of dose of pain medication', 'timeFrame': '25 months', 'description': 'variation of dosage of pain medication between inclusion and the end of radiotherapy (mg, number of caps, ...)'}, {'measure': 'toxicity due to radiotherapy', 'timeFrame': '25 months', 'description': 'Toxicity 4 weeks after radiotherapy with NCI-CTC-AE v4'}, {'measure': 'overall survey', 'timeFrame': '36 months', 'description': 'Time between inclusion and death'}, {'measure': 'To evaluate free progression survival', 'timeFrame': '36 months', 'description': 'Time between inclusion and first progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['irradiation', 'placebo', 'carboplatin'], 'conditions': ['Lung Cancer', 'Head and Neck Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'The study population has locally advanced or metastatic bronchial or head and neck cancer.\n\nThis study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone.\n\nThe realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. In addition, a benefit in overall survival is possible.', 'detailedDescription': 'The study population has locally advanced or metastatic bronchial or head and neck cancer.\n\nPatients receive 10 injections of carboplatin (validated chemo-sensitizing molecule) or placebo (glucose) before 10 radiation sessions.\n\nThe overall duration is 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with locally advanced or metastatic bronchial or head and neck cancer\n* Patient require palliative radiotherapy\n* Age ≥ 18 years\n* PS ≤ 2\n* Obtaining the signed written consent of the patient\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Other chemotherapy or targeted therapy\n* Prior radiation\n* Patients with thrombopenia \\< 100 000\n* Patients with neutropenia \\< 2000\n* Patients with renal clearance \\< 20 mL/min\n* Known hypersensitivity to platinum salt\n* Treatment with phenytoin or fosphenytoin\n* In previous three months, a vaccination against yellow fever, live vaccin or live attenuated vaccine\n* Unchecked diabetes\n* hemorrhagic tumor\n* Refusal of participation or inability to issue informed consent\n* Person deprived of liberty or adult under guardianship\n* Minor patients, pregnant or lactating women\n* Participation in other interventional study'}, 'identificationModule': {'nctId': 'NCT03637335', 'acronym': 'METAXIOM', 'briefTitle': 'Comparing Palliative Radiotherapy With or Without Carboplatin', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin', 'orgStudyIdInfo': {'id': 'ICO-A-2014-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'irradiation + carboplatin', 'description': 'Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Carboplatin. :10 injections 1h prior irradiation', 'interventionNames': ['Combination Product: irradiation + carboplatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'irradiation + placebo', 'description': 'Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Placebo :10 injections 1h prior irradiation', 'interventionNames': ['Combination Product: irradiation + placebo']}], 'interventions': [{'name': 'irradiation + carboplatin', 'type': 'COMBINATION_PRODUCT', 'description': '30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin', 'armGroupLabels': ['irradiation + carboplatin']}, {'name': 'irradiation + placebo', 'type': 'COMBINATION_PRODUCT', 'description': '30 Gy en 10 fractions de 3 Gy + 10 injections of placebo', 'armGroupLabels': ['irradiation + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Fabrice Denis', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Nantes', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'FABRICE DENIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Jean Bernard'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}