Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT01032967
Status:
COMPLETED
Last Update Posted:
2009-12-16
First Post:
2009-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgery or Chemoradiation for Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016629', 'term': 'Esophagectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-15', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival and disease-free survival', 'timeFrame': '2 year and 5 year'}], 'secondaryOutcomes': [{'measure': 'Quality of life and function outcomes', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['squamous cell carcinoma', 'esophagectomy', 'chemoradiotherapy', 'chemoradiation', 'Squamous cell carcinomas of the esophagus'], 'conditions': ['Esophageal Cancers']}, 'referencesModule': {'references': [{'pmid': '22887465', 'type': 'DERIVED', 'citation': 'Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.'}, {'pmid': '21233603', 'type': 'DERIVED', 'citation': 'Teoh AY, Yan Chiu PW, Wong TC, Liu SY, Hung Wong SK, Ng EK. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: results from a randomized trial. Ann Surg. 2011 Jan;253(1):1-5. doi: 10.1097/SLA.0b013e3181fcd991.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients had mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable.\n\nExclusion Criteria:\n\n* The investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.\n* Those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also excluded.'}, 'identificationModule': {'nctId': 'NCT01032967', 'briefTitle': 'Surgery or Chemoradiation for Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Multicenter Prospective Randomized Trial Comparing Standard Esophagectomy With Chemoradiotherapy for Treatment of Squamous Esophageal Cancer: Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)', 'orgStudyIdInfo': {'id': 'Surgery or CRT Ca Esophagus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery, esophagectomy', 'description': 'The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy', 'interventionNames': ['Procedure: Esophagectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Definitive chemoradiation', 'description': '3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.', 'interventionNames': ['Radiation: Definitive chemoradiation']}], 'interventions': [{'name': 'Esophagectomy', 'type': 'PROCEDURE', 'description': 'The patients will receive standard open esophagectomy with two-field lymphadenectomy', 'armGroupLabels': ['Surgery, esophagectomy']}, {'name': 'Definitive chemoradiation', 'type': 'RADIATION', 'description': '3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.', 'armGroupLabels': ['Definitive chemoradiation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Philip W Chiu, FRCSEd (Gen)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Philip Chiu', 'oldOrganization': 'Chinese University of Hong Kong'}}}}