Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT01015534
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2009-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cswgamboa@yahoo.com', 'phone': '0155556280400', 'title': 'Carlos Gamboa Vignolle/ Radiation Oncologist', 'phoneExt': '441', 'organization': 'Instituto Nacional de Cancerologia de Mexico'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our study had methodological limitations, such as the two temozolomide dose levels, which in future clinical trials may be adjusted to a single level.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.', 'eventGroups': [{'id': 'EG000', 'title': 'Whole Brain Irradiation and Temozolomide', 'description': 'Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.', 'otherNumAtRisk': 28, 'otherNumAffected': 11, 'seriousNumAtRisk': 28, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Whole Brain Irradiation', 'description': 'Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.', 'otherNumAtRisk': 27, 'otherNumAffected': 13, 'seriousNumAtRisk': 27, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Lymphopenia', 'notes': 'Grade 1 \\< Low limit of normal (LLN) - 800/mm3. Grade 2 \\<800 - 500/mm3.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'platelets', 'notes': 'Grade 1 \\<LLN-75,000/mm3. Grade 2 \\<75,000-50,000/mm3.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alanine aminotransferase - Aspartate aminotransferase', 'notes': 'Alanine aminotransferase Grade 1 \\> Upper limit of normal (ULN) - 2.5 x ULN Aspartate aminotransferase Grade 1 \\> ULN - 2.5 x ULN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Lymphopenia', 'notes': 'Grade 3 \\<500 - 200 mm3. Grade 4 \\<200/mm3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukopenia', 'notes': 'Grade 3 \\<2000 - 1000/mm3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'notes': 'Grade 3 \\<50,000 - 25,000/mm3. Grade 4 \\<25,000/mm3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils', 'notes': 'Grade 3 \\<1000 - 500/mm3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea-Vomiting', 'notes': 'Grade 3 ≥6 episodes in 24 hrs; IV fluids, indicated\n\n≥24 hrs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '3.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rates. Assessed With Cranial MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Brain Irradiation and Temozolomide', 'description': 'Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.'}, {'id': 'OG001', 'title': 'Whole Brain Irradiation', 'description': 'Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '63.4', 'upperLimit': '93.8'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '29.2', 'upperLimit': '66.9'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '1.3', 'ciUpperLimit': '12.9', 'pValueComment': 'The sample size was calculated with a two-sided test,a type-I error probability of 0.05 and a power of 0.80,Twenty- eight patients in each treatment arm were required to detect a difference in ORR of 0.29', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI.\n\nObjective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants.', 'unitOfMeasure': 'Percentage of participants with OR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on all enrolled participants were included in an intention-to-treat analysis.'}, {'type': 'SECONDARY', 'title': 'Survival Free of Brain Metastases Progression (PFS of BM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Brain Irradiation and Temozolomide', 'description': 'Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.'}, {'id': 'OG001', 'title': 'Whole Brain Irradiation', 'description': 'Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '100'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '98.4'}]}]}], 'analyses': [{'pValue': '.704', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.688', 'ciLowerLimit': '.138', 'ciUpperLimit': '3.422', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at 90 days', 'description': 'Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on all enrolled participants were included in an intention-to-treat analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Brain Irradiation and Temozolomide', 'description': 'Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.'}, {'id': 'OG001', 'title': 'Whole Brain Irradiation', 'description': 'Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '11.1'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '10.1'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.', 'unitOfMeasure': 'Months of Overall Survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on all enrolled participants were included in an intention-to-treat analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Brain Irradiation and Temozolomide', 'description': 'Whole brain irradiation, Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks,and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.'}, {'id': 'OG001', 'title': 'Whole Brain Irradiation', 'description': 'Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks'}], 'classes': [{'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0\n\nGrade 3 Severe AE.\n\nGrade 4 Life-threatening or disabling AE.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were assessed with a Complete blood count at the end of the first and second weeks of treatment. A standard biochemical profile was performed at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Participants also were evaluated clinically with the same periodicity .'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Whole Brain Irradiation and Temozolomide', 'description': 'Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.'}, {'id': 'FG001', 'title': 'Whole Brain Irradiation', 'description': 'Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from patients from Instituto Nacional de Cancerología de México, from January 2006 to September 2008.', 'preAssignmentDetails': 'Seventy-two patients were assessed for eligibility. Twelve patients did not meet inclusion criteria. Five patients declined to participate. Fifty-five patients were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Whole Brain Irradiation and Temozolomide', 'description': 'Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.'}, {'id': 'BG001', 'title': 'Whole Brain Irradiation', 'description': 'Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '53.8', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '13.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-25', 'studyFirstSubmitDate': '2009-11-17', 'resultsFirstSubmitDate': '2012-08-23', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-25', 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rates. Assessed With Cranial MRI', 'timeFrame': '90 days', 'description': 'Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI.\n\nObjective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants.'}], 'secondaryOutcomes': [{'measure': 'Survival Free of Brain Metastases Progression (PFS of BM)', 'timeFrame': 'at 90 days', 'description': 'Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.'}, {'measure': 'Overall Survival', 'timeFrame': '1 year', 'description': 'Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.'}, {'measure': 'Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.', 'timeFrame': '4 months', 'description': 'AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0\n\nGrade 3 Severe AE.\n\nGrade 4 Life-threatening or disabling AE.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Brain metastases', 'Temozolomide', 'Whole-brain radiotherapy', 'Phase II trial'], 'conditions': ['Brain Neoplasms']}, 'referencesModule': {'references': [{'pmid': '16134182', 'type': 'BACKGROUND', 'citation': 'Jones SF, Greco FA, Gian VG, Miranda FT, Raefsky EL, Hainsworth JD, Willcutt NT, Beschorner AF, Kennerly G, Burris HA 3rd. A Phase I trial of protracted oral fixed-dose temozolomide. Cancer. 2005 Nov 1;104(9):1985-91. doi: 10.1002/cncr.21408.'}, {'pmid': '12202665', 'type': 'BACKGROUND', 'citation': 'Antonadou D, Paraskevaidis M, Sarris G, Coliarakis N, Economou I, Karageorgis P, Throuvalas N. Phase II randomized trial of temozolomide and concurrent radiotherapy in patients with brain metastases. J Clin Oncol. 2002 Sep 1;20(17):3644-50. doi: 10.1200/JCO.2002.04.140.'}, {'pmid': '15629610', 'type': 'BACKGROUND', 'citation': 'Verger E, Gil M, Yaya R, Vinolas N, Villa S, Pujol T, Quinto L, Graus F. Temozolomide and concomitant whole brain radiotherapy in patients with brain metastases: a phase II randomized trial. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):185-91. doi: 10.1016/j.ijrobp.2004.04.061.'}, {'pmid': '22257825', 'type': 'DERIVED', 'citation': 'Gamboa-Vignolle C, Ferrari-Carballo T, Arrieta O, Mohar A. Whole-brain irradiation with concomitant daily fixed-dose temozolomide for brain metastases treatment: a randomised phase II trial. Radiother Oncol. 2012 Feb;102(2):187-91. doi: 10.1016/j.radonc.2011.12.004. Epub 2012 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE\n\n* Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.\n\nPURPOSE\n\n* This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.', 'detailedDescription': 'Primary Outcome Measures\n\n* Objective Response Rates\n\nSecondary Outcome Measures\n\n* Survival Free of Brain Metastases progression\n* Overall Survival\n* Systemic Side effects\n\nObjectives\n\nPrimary\n\n* Compare objective response rates in both arms of treatment\n\nSecondary\n\n* Compare survival free of progression in both arms of treatment\n* Compare Overall Survival in both arms of treatment\n* Compare side effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Karnofsky performance status (KPS) ≥ 50\n* Life expectancy ≥ 12 weeks\n* Histologically confirmed non lymphomatous solid tumors at primary site\n* Brain metastases diagnosed with cranial MRI/CT.\n* Extracranial metastases or primary tumor uncontrolled are allowed\n* Hemoglobin ≥ 10 g/dl\n* Absolute neutrophil count of \\> 1500/mm3\n* Platelet count of ≥ 100,000/mm3\n* Blood urea nitrogen (BUN) ≤ 25 mg/dl,\n* Serum creatinin ≤ 1.5 mg/dl\n* Serum bilirubins ≤ 1.5 mg/dl,\n* Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper normal limit\n\nExclusion Criteria\n\n* Pregnant or breast feeding woman\n* History of allergic reaction to iodinated contrast media\n* Inability to swallow\n* Systemic chemotherapy in previous 3 weeks\n* Oral chemotherapy in previous 2 weeks\n* Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm\n* Meningeal carcinomatosis'}, 'identificationModule': {'nctId': 'NCT01015534', 'briefTitle': 'Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cancerologia de Mexico'}, 'officialTitle': 'Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment', 'orgStudyIdInfo': {'id': '006/004/TEI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole brain irradiation plus Temozolomide', 'description': 'Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.', 'interventionNames': ['Drug: Temozolomide', 'Radiation: Whole brain irradiation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole brain irradiation', 'description': 'Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks', 'interventionNames': ['Radiation: Whole brain irradiation']}], 'interventions': [{'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodar', 'or', 'Temodal'], 'armGroupLabels': ['Whole brain irradiation plus Temozolomide']}, {'name': 'Whole brain irradiation', 'type': 'RADIATION', 'otherNames': ['Whole brain radiotherapy'], 'armGroupLabels': ['Whole brain irradiation', 'Whole brain irradiation plus Temozolomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'México', 'state': 'D.F', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cancerología de México', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}], 'overallOfficials': [{'name': 'Carlos Gamboa-Vignolle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Cancerología de México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cancerologia de Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Carlos Gamboa Vignolle', 'investigatorAffiliation': 'Instituto Nacional de Cancerologia de Mexico'}}}}