Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-01 @ 6:52 PM
Study NCT ID:
NCT00964457
Status:
UNKNOWN
Last Update Posted:
2009-08-25
First Post:
2009-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before, Under and After Radiation and With Adding Cetuximab to K-RAS Wild-type Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal 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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-24', 'studyFirstSubmitDate': '2009-08-21', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cetuximab', 'rectum cancer', 'radiation', 'MRI'], 'conditions': ['Rectum Cancer']}, 'descriptionModule': {'briefSummary': 'response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer', 'detailedDescription': 'Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced rectum cancer\n\nExclusion Criteria:\n\n* prior radiation'}, 'identificationModule': {'nctId': 'NCT00964457', 'briefTitle': 'Treatment of Patients With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before, Under and After Radiation and With Adding Cetuximab to K-RAS Wild-type Patients', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Treatment of Patient With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before Under and After Radiation and With Adding Cetuximab to K_RAS Wild-type Patients.', 'orgStudyIdInfo': {'id': 'GI0905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine, oxaliplatin', 'interventionNames': ['Drug: cetuximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'capecitabine, oxaliplatin and cetuximab', 'description': 'capecitabine, oxaliplatin ane cetuximab', 'interventionNames': ['Drug: cetuximab']}], 'interventions': [{'name': 'cetuximab', 'type': 'DRUG', 'description': 'cetuximab 500mg per meter square every second week', 'armGroupLabels': ['Capecitabine, oxaliplatin', 'capecitabine, oxaliplatin and cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ole Larsen, MD, Herlev hospital', 'oldOrganization': 'hospital'}}}}