Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT00238251
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy Combined With Either Gefitinib or Temozolomide in Pats With NSCLC and Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-04', 'studyFirstSubmitDate': '2005-10-12', 'studyFirstSubmitQcDate': '2005-10-12', 'lastUpdatePostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'life-long'}], 'secondaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': '28 days'}, {'measure': 'Time to neurological progression', 'timeFrame': '28 days'}, {'measure': 'Time to extracranial disease progression', 'timeFrame': '28 days'}, {'measure': 'Adverse events as measured at completion of study treatment', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV non-small cell lung cancer', 'recurrent non-small cell lung cancer', 'tumors metastatic to brain'], 'conditions': ['Lung Cancer', 'Metastatic Cancer']}, 'referencesModule': {'references': [{'pmid': '22093943', 'type': 'RESULT', 'citation': "Pesce GA, Klingbiel D, Ribi K, Zouhair A, von Moos R, Schlaeppi M, Caspar CB, Fischer N, Anchisi S, Peters S, Cathomas R, Bernhard J, Kotrubczik NM, D'Addario G, Pilop C, Weber DC, Bodis S, Pless M, Mayer M, Stupp R. Outcome, quality of life and cognitive function of patients with brain metastases from non-small cell lung cancer treated with whole brain radiotherapy combined with gefitinib or temozolomide. A randomised phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 70/03). Eur J Cancer. 2012 Feb;48(3):377-84. doi: 10.1016/j.ejca.2011.10.016. Epub 2011 Nov 15."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with either gefitinib or temozolomide may kill more tumor cells.\n\nPURPOSE: This randomized phase II trial is studying how well giving radiation therapy together with either gefitinib or temozolomide works in treating patients with non-small cell lung cancer and brain metastases.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the efficacy of whole-brain radiotherapy combined with either gefitinib or temozolomide, in terms of overall survival, in patients with non-small cell lung cancer and brain metastases.\n\nSecondary\n\n* Compare the tolerability and toxicity of these regimens in these patients.\n* Compare the time to neurological disease progression, time to extracranial disease progression, and time to overall disease progression, in patients treated with these regimens.\n* Compare adverse events in patients treated with these regimens.\n* Compare cognitive function and quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are stratified according to extracranial disease (yes vs no), number of brain metastases (1-3 vs ≥ 4), prior chemotherapy (yes vs no), WHO performance status (0-1 vs 2), and participating center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo whole-brain radiotherapy (WBRT) once daily on days 1-5 and 8-12 and receive oral gefitinib once daily on days 1-28. Gefitinib treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients undergo WBRT as in arm I and receive oral temozolomide once daily on days 1-21. Temozolomide treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline and on day 1 of courses 2, 3, and 5.\n\nAfter completion of study therapy, patients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 30-86 patients (15-43 per treatment arm) will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer AND newly diagnosed brain metastases meeting 1 of the following criteria:\n\n * Multiple brain metastases\n * Single brain metastasis not amenable to potentially curative treatment\n* No advanced extracranial disease severely compromising vital functions and performance\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Hemoglobin \\> 10 g/dL\n* Absolute neutrophil count \\> 1,500/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* AST and ALT ≤ 2.5 times ULN\n* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of documented bone metastases)\n* No unstable or uncompensated hepatic disease that would preclude study participation\n\nRenal\n\n* Creatinine clearance ≥ 40 mL/min\n* No unstable or uncompensated renal disease that would preclude study participation\n\nCardiovascular\n\n* No myocardial infarction within the past 3 months\n* No unstable or uncompensated cardiac disease that would preclude study participation\n\nPulmonary\n\n* No clinically active interstitial lung disease\n\n * Patients with chronic stable radiographic changes who are asymptomatic eligible\n* No other unstable or uncompensated respiratory disease that would preclude study participation\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 12 months after completion of study treatment\n* No nausea, vomiting, inability to swallow whole tablets/capsules, or malabsorption syndrome that would preclude oral medication ingestion or absorption\n* No psychiatric disorder that would preclude giving informed consent or study compliance\n* No active infection\n* No uncontrolled diabetes mellitus\n* No other medical condition that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior temozolomide\n\nEndocrine therapy\n\n* Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 4 days before study entry\n\nRadiotherapy\n\n* No prior brain irradiation\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior gefitinib or erlotinib\n* More than 30 days since prior investigational clinical trial participation\n* No other concurrent experimental drugs\n* No other concurrent anticancer therapy\n* No concurrent treatment with any of the following:\n\n * Phenytoin\n * Carbamazepine\n * Rifampin\n * Barbiturates\n * Hypericum perforatum (St. John's wort)\n * Other enzyme-inducing anti-epileptic drugs or tuberculostatic treatments\n * Any drug that contraindicates administration with study drugs"}, 'identificationModule': {'nctId': 'NCT00238251', 'briefTitle': 'Radiation Therapy Combined With Either Gefitinib or Temozolomide in Pats With NSCLC and Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Cancer Institute'}, 'officialTitle': 'Whole Brain Radiotherapy in Combination With Gefitinib (Iressa) or Temozolomide (Temodal) for Brain Metastases From Non-Small Lung Cancer (NSCLC) A Randomized Phase II Trial', 'orgStudyIdInfo': {'id': 'SAKK 70/03'}, 'secondaryIdInfos': [{'id': 'EU-20526'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I', 'description': 'Patients undergo whole-brain radiotherapy (WBRT) once daily on days 1-5 and 8-12 and receive oral gefitinib once daily on days 1-28. Gefitinib treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity', 'interventionNames': ['Drug: gefitinib', 'Radiation: radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II', 'description': 'Patients undergo WBRT as in arm I and receive oral temozolomide once daily on days 1-21. Temozolomide treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity', 'interventionNames': ['Drug: temozolomide', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'gefitinib', 'type': 'DRUG', 'description': 'Once daily during days 1-28', 'armGroupLabels': ['Arm I']}, {'name': 'temozolomide', 'type': 'DRUG', 'description': 'Once daily on days 1-21', 'armGroupLabels': ['Arm II']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Whole brain radiotherapy', 'armGroupLabels': ['Arm I', 'Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Oncology Institute of Southern Switzerland', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': 'CH-7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Kantonsspital Graubuenden', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Gianfranco Pesce, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni'}, {'name': 'Roger Stupp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}