Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-23 @ 9:23 PM
Study NCT ID:
NCT01363557
Status:
TERMINATED
Last Update Posted:
2014-05-13
First Post:
2011-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Decision of Sponsor', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-12', 'studyFirstSubmitDate': '2011-05-25', 'studyFirstSubmitQcDate': '2011-05-31', 'lastUpdatePostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the objective response rate of brain metastases in each arm', 'timeFrame': 'at 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with neurological Adverse Events', 'timeFrame': 'at 6 weeks, 3 months, 4.5 months and 6 months'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'at 6 months'}, {'measure': 'Overall survival', 'timeFrame': 'at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized', 'Brain Radiation Therapy', 'Lung Cancer', 'Brain Metastasis', 'Gefitinib'], 'conditions': ['EGFR-mutated Lung Adenocarcinoma', 'Brain Metastasis']}, 'descriptionModule': {'briefSummary': 'Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.', 'detailedDescription': 'Lung cancer patients with newly diagnosed CNS metastasis with- at least one brain lesion measuring \\> 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryOpen-label, multicentre, national, randomised (1:1) phase II trialArm A: WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Arm B: Gefitinib'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have signed a written informed consent form prior to any study specific screening procedures\n* 18 years or older\n* KPS ≥ 50%\n* Histologically confirmed adenocarcinoma of the lung\n* Activating mutation of EGFR\n* Newly diagnosed CNS metastasis or in progression with at least one measurable lesion in the brain (defined as any lesion \\> 1 cm on T1-weighted contrast enhanced MRI)\n* Patients could enter the study regardless of previous treatment (included chemotherapy) for metastatic extracranial disease, except TKI.\n* No steroids or stable or decreasing dose of steroids for at least 5 days before the MRI evaluation.\n* Adequate hematologic, liver and renal functions: neutrophil count ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; Hb ≥ 9 g/Dl; Total bilirubin \\< 1.5 x ULN; AST or ALT \\< 2.5 x ULN (\\< 5 x ULN in patients with liver metastases); Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min\n\nExclusion Criteria:\n\n* Prior treatment of brain metastases with WBRT or TKI\n* Patient eligible for radiosurgery or surgical resection\n* Contre indication at the radiotherapy\n* Leptomeningeal disease\n* Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) within the the 5 years before study entry\n* Prior treatment with Gefitinib or other TKI\n* Pregnant or breast feeding women\n* Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception'}, 'identificationModule': {'nctId': 'NCT01363557', 'acronym': 'ARPEGE', 'briefTitle': 'Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Randomized to Assess the Efficacy of Whole Brain Radiation Therapy (WBRT) With Concomitant Gefitinib Followed by Maintenance Gefitinib, and Gefitinib Alone, in Lung Cancer Patients With Brain Metastasis', 'orgStudyIdInfo': {'id': 'P100601'}, 'secondaryIdInfos': [{'id': '2010-A01332-37', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A : Gefitinib + WBRT', 'description': 'Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance', 'interventionNames': ['Other: whole brain radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B : Gefitinib', 'description': 'Arm B : Gefitinib alone', 'interventionNames': ['Drug: Gefitinib (IRESSA)']}], 'interventions': [{'name': 'whole brain radiotherapy', 'type': 'OTHER', 'description': 'External beam RT using a total dose of 30 Gy with ten daily fractions of 3.0 Gy given 5 days per week over 2 weeks + Gefitinib 250 mg/day', 'armGroupLabels': ['Arm A : Gefitinib + WBRT']}, {'name': 'Gefitinib (IRESSA)', 'type': 'DRUG', 'description': '250 mg/day', 'armGroupLabels': ['Arm B : Gefitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Service de Neurologie - Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'overallOfficials': [{'name': 'Antoine CARPENTIER, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}