Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT00278694
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2006-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin and 5-FU Based Preoperative Chemoradiation
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': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-28', 'studyFirstSubmitDate': '2006-01-16', 'studyFirstSubmitQcDate': '2006-01-16', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety profile', 'timeFrame': '5 years'}, {'measure': 'Number of patients obtaining pCR', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Clinical, radiological and molecular response to treatment', 'timeFrame': '5 years'}]}, 'conditionsModule': {'keywords': ['Oxaliplatin, radiation'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '31122213', 'type': 'DERIVED', 'citation': 'Abrahamsson H, Porojnicu AC, Lindstrom JC, Dueland S, Flatmark K, Hole KH, Seierstad T, Moan J, Redalen KR, Meltzer S, Ree AH. High level of circulating vitamin D during neoadjuvant therapy may lower risk of metastatic progression in high-risk rectal cancer. BMC Cancer. 2019 May 23;19(1):488. doi: 10.1186/s12885-019-5724-z.'}, {'pmid': '27461255', 'type': 'DERIVED', 'citation': 'Kalanxhi E, Hektoen HH, Meltzer S, Dueland S, Flatmark K, Ree AH. Circulating proteins in response to combined-modality therapy in rectal cancer identified by antibody array screening. BMC Cancer. 2016 Jul 26;16:536. doi: 10.1186/s12885-016-2601-x.'}, {'pmid': '26205955', 'type': 'DERIVED', 'citation': 'Hektoen HH, Flatmark K, Andersson Y, Dueland S, Redalen KR, Ree AH. Early increase in circulating carbonic anhydrase IX during neoadjuvant treatment predicts favourable outcome in locally advanced rectal cancer. BMC Cancer. 2015 Jul 24;15:543. doi: 10.1186/s12885-015-1557-6.'}, {'pmid': '25624177', 'type': 'DERIVED', 'citation': 'Ree AH, Flatmark K, Saelen MG, Folkvord S, Dueland S, Geisler J, Redalen KR. Tumor phosphatidylinositol 3-kinase signaling in therapy resistance and metastatic dissemination of rectal cancer: opportunities for signaling-adapted therapies. Crit Rev Oncol Hematol. 2015 Jul;95(1):114-24. doi: 10.1016/j.critrevonc.2015.01.003. Epub 2015 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.', 'detailedDescription': 'Effect of treatment, safety profile and quality of life scorings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Rectal cancer'}, 'identificationModule': {'nctId': 'NCT00278694', 'acronym': 'LARC-RRP', 'briefTitle': 'Oxaliplatin and 5-FU Based Preoperative Chemoradiation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Oxaliplatin and 5-FU Based Preoperative Chemoradiation', 'orgStudyIdInfo': {'id': 'S-05059'}, 'secondaryIdInfos': [{'id': 'Eudractnr 2005-000024-16'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemoradiation', 'description': 'Neoadjuvant chemotherapy and chemoradiation', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Chemoradiation', 'Drug: 5-FU', 'Radiation: Preoperative chemoradiation', 'Procedure: Pelvic surgery', 'Drug: Neoadjuvant oxaliplatin']}], 'interventions': [{'name': 'Oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['Chemoradiation']}, {'name': 'Chemoradiation', 'type': 'DRUG', 'armGroupLabels': ['Chemoradiation']}, {'name': '5-FU', 'type': 'DRUG', 'armGroupLabels': ['Chemoradiation']}, {'name': 'Preoperative chemoradiation', 'type': 'RADIATION', 'armGroupLabels': ['Chemoradiation']}, {'name': 'Pelvic surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Chemoradiation']}, {'name': 'Neoadjuvant oxaliplatin', 'type': 'DRUG', 'armGroupLabels': ['Chemoradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'RRHF', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Georg Høyer, DH', 'role': 'STUDY_CHAIR', 'affiliation': 'South region committee for research ethics in Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant medical oncology', 'investigatorFullName': 'Svein Dueland', 'investigatorAffiliation': 'Oslo University Hospital'}}}}