Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 8:33 AM
Study NCT ID:
NCT00003803
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed
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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage III non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '17084621', 'type': 'RESULT', 'citation': 'Belderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C; EORTC LCG and RT Group. Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973). Eur J Cancer. 2007 Jan;43(1):114-21. doi: 10.1016/j.ejca.2006.09.005. Epub 2006 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor cells. It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage II, or stage III non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare survival, disease-free survival, local control, and pattern of recurrence in patients with unresectable stage I, II, or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin.\n* Compare the acute and late toxic effects of these regimens in these patients.\n* Determine the quality of life of these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2. Treatment is repeated once 21 days later. Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 (day 57), 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy.\n* Arm II: Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy. Treatment continues daily, 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy.\n\nQuality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35.\n\nPatients are followed at 3 weeks, 6-7 weeks, and then every 8 weeks thereafter.\n\nPROJECTED ACCRUAL: A total of 418 patients (209 per arm) will be accrued for this study within 5 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\n\n * Stage I, II, III (T1-4, N0-3, M0)\n\n * No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes\n * Medically inoperable or unresectable\n* No pleural or pericardial effusion (except with repeated negative cytology)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* ECOG 0 or 1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 4,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 6.8 g/dL\n* No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Creatinine no greater than 1.25 times normal OR\n* Creatinine clearance greater than 70 mL/min\n\nCardiovascular:\n\n* No evidence of heart failure\n* No myocardial infarction within the past 6 months\n* No superior vena cava syndrome\n\nPulmonary:\n\n* FEV1 at least 1 L\n* No pre-existing fibrotic lung disease\n* No postobstructive pneumonia preventing exact delineation of tumor volume\n* Diffusion capacity at least 60%\n\nOther:\n\n* No weight loss of more than 10% in the past 3 months\n* No uncontrolled infection\n* No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* No prior chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy to the chest\n* Maximum length of the esophagus receiving 40 Gy no greater than 18 cm\n* Maximum length of the esophagus receiving 66 Gy no greater than 12 cm\n* Must limit the spinal cord dose to a maximum of 50 Gy\n* Must be able to exclude 25% of the heart from the boost volume\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No other concurrent experimental medications'}, 'identificationModule': {'nctId': 'NCT00003803', 'briefTitle': 'Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III', 'orgStudyIdInfo': {'id': 'EORTC-08972-22973'}, 'secondaryIdInfos': [{'id': 'EORTC-08972'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '7100', 'city': 'Haine-Saint-Paul', 'country': 'Belgium', 'facility': 'Hopital de Jolimont', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHR de Grenoble - La Tronche', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': 'D-54219', 'city': 'Trier', 'country': 'Germany', 'facility': 'Mutterhaus der Borromaerinnen', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '2501 CK', 'city': "'s-Gravenhage (Den Haag, the Hague)", 'country': 'Netherlands', 'facility': 'Medisch Centrum Haaglanden', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Antoni van Leeuwenhoekhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7334 DZ', 'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuizen - Lokatie Lukas', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '4810 EV', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '4818 CK', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis - locatie Molengracht', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': 'NL 2600 GA', 'city': 'Delft', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Group', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'zip': '7400 AC', 'city': 'Deventer', 'country': 'Netherlands', 'facility': 'Radiotherapeutisch Instituut-(Riso)', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'zip': '5602 ZA', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '5042 AD', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Twee Steden Ziekenhuis Vestiging Tilburg', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '5042 SB', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Dr. Bernard Verbeeten Instituut', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '8000 GK', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Sophia Ziekehuis', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Jose Belderbos, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Netherlands Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}