Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT00062335
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2003-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2003-06-05', 'studyFirstSubmitQcDate': '2003-06-05', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter'}, {'measure': 'Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter'}]}, 'conditionsModule': {'keywords': ['stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I, II, or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated.\n* Determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients.\n\nOUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25% vs 25-37% vs over 37%).\n\n* Stratum I: Patients undergo high-dose 3-dimensional (3-D) conformal radiotherapy 5 days a week for 6 weeks.\n* Stratum II: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-7 weeks.\n* Stratum III: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-6.5 weeks.\n\nCohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy (either by increasing the total dose or by shortening treatment time) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity.\n\nPatients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 54-135 patients (18-45 per stratum) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer\n\n * Medically inoperable stage I or II disease\n * Stage III disease eligible provided the following are true:\n\n * No supraclavicular node involvement\n * No peripherally located lower lobe tumor AND contralateral upper mediastinal node involvement\n* No distant metastasis\n* No malignant pleural or pericardial effusion\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Not specified\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No prior myocardial infarction\n* No prior complete bundle branch block\n* No other prior cardiovascular disease resulting in New York Heart Association class III or IV heart disease\n* No clinically significant cardiac arrhythmias\n* No congestive heart failure\n\nPulmonary\n\n* FEV\\_1 at least 1.2 L OR\n* DLCO at least 60%\n\nOther\n\n* No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix\n* No intractable or uncontrolled infection\n* No psychological, familial, social, or geographical condition that would preclude study compliance and follow-up\n* Able to tolerate a course of radiotherapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* At least 3 weeks since prior chemotherapy\n* No prior anthracyclines\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy to the chest area\n\nSurgery\n\n* No prior therapeutic surgery to the chest area\n\nOther\n\n* No other prior therapy to the chest area'}, 'identificationModule': {'nctId': 'NCT00062335', 'briefTitle': 'High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'EORTC-22994'}, 'secondaryIdInfos': [{'id': 'EORTC-22994'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Academisch Ziekenhuis der Vrije Universiteit Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Akademisch Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75248', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie - Section Medicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Jacques Bernier, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}