Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-29 @ 12:14 AM
Study NCT ID:
NCT00115518
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2005-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2005-06-22', 'studyFirstSubmitQcDate': '2005-06-22', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)', 'timeFrame': '3 yrs'}], 'secondaryOutcomes': [{'measure': 'response (RECIST criteria of primary tumor and enlarged lymphnodes)', 'timeFrame': '3 yrs'}, {'measure': 'survival (at 3 years)', 'timeFrame': '3 yrs'}, {'measure': 'time to progression (locally and systemically)', 'timeFrame': '3 yrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '21264838', 'type': 'RESULT', 'citation': 'Jensen AD, Munter MW, Bischoff HG, Haselmann R, Haberkorn U, Huber PE, Thomas M, Debus J, Herfarth KK. Combined treatment of nonsmall cell lung cancer NSCLC stage III with intensity-modulated RT radiotherapy and cetuximab: the NEAR trial. Cancer. 2011 Jul 1;117(13):2986-94. doi: 10.1002/cncr.25888. Epub 2011 Jan 24.'}, {'pmid': '16681848', 'type': 'DERIVED', 'citation': 'Jensen AD, Munter MW, Bischoff H, Haselmann R, Timke C, Krempien R, Sterzing F, Nill S, Heeger S, Hoess A, Haberkorn U, Huber PE, Steins M, Thomas M, Debus J, Herfarth KK. Treatment of non-small cell lung cancer with intensity-modulated radiation therapy in combination with cetuximab: the NEAR protocol (NCT00115518). BMC Cancer. 2006 May 8;6:122. doi: 10.1186/1471-2407-6-122.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial).\n\nEndpoints:\n\nsafety and feasibility (primary) response, survival, time to progression (secondary)', 'detailedDescription': 'Study entry examinations:\n\n* blood cell count\n* liver enzymes\n* ventilatory function test\n* pregnancy test (premenopausal women)\n* CT of the thorax\n* CT of the brain\n* Ultrasound of the liver\n* Bone scan\n* FDG PET scan (after inclusion)\n\nFollow-up examinations (2 months, than every 3 months):\n\n* patients history and examination\n* CT scan of the thorax\n* ventilatory functions test\n* FDG PET scan (at least at 6 months)\n* bone scan (yearly)\n* ultrasound of the liver (every 6 months)\n\nCetuximab administration:\n\n* 450 mg / m\\^2 body surface on week 1\n* 250 mg /m\\^2 body surface weekly, week 2 -21\n\nRadiation therapy:\n\n* intensity modulated radiation therapy of primary tumor and mediastinum (2 Gy single dose, total dose 50 Gy; 5 fractions per week) with boost to the PET positive sites (2 Gy single doses up to 66 Gy). Radiation therapy during weeks 2-8.\n\nAmendment 1/07: 3D conformal RT possible, but not if FeV1 \\< 1.5L of \\< 50%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically verified NSCLC\n* Not eligible for Radiochemotherapy or patient refuses chemotherapy\n* FeV1 \\>1.5 L or min. 50%\n* KPI \\>= 70%\n* Life expectancy \\> 6 months\n* Weight loss less than 10% of body weight in 12 months\n* Compliance\n* Adequate blood counts (LC \\> 3000 x 10\\^3/ml, Tc \\>100000 x 10\\^3/ml, Hb \\> 10 g/dl)\n* Effective contraception\n\nAmendment 1/07: FeV1 \\>1.2 L or min 40%\n\nExclusion Criteria:\n\n* Active infection\n* Reduced liver function\n* Vena cava superior syndrome\n* Malignant pleural effusion\n* Pregnancy or breast feeding\n* Additional serious systemic disease\n* Secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for \\> 5 years)\n* Known allergies against proteins\n* History of former antibody therapy\n* Allergy against i.v. contrast agents'}, 'identificationModule': {'nctId': 'NCT00115518', 'briefTitle': 'Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III', 'orgStudyIdInfo': {'id': 'NEAR L-284/2004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cetuximab', 'type': 'DRUG', 'description': 'After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Klaus K Herfarth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Klaus Herfarth, MD', 'oldOrganization': 'UJniversity of Heidelberg'}}}}