Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT00800969
Status:
WITHDRAWN
Last Update Posted:
2016-06-23
First Post:
2008-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'lastUpdateSubmitDate': '2016-06-22', 'studyFirstSubmitDate': '2008-11-28', 'studyFirstSubmitQcDate': '2008-12-02', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy of PET-CT', 'timeFrame': 'preoperative'}]}, 'conditionsModule': {'keywords': ['Adenocarcinoma of the stomach and esophagogastric junction'], 'conditions': ['Adenocarcinoma', 'Stomach Cancer', 'Cancer of Esophagogastric Junction']}, 'descriptionModule': {'briefSummary': 'This prospective study includes patients with histologically proven cancer of the esophagogastric junction (Siewert Type II and III) and the stomach. Aim of the study is to evaluate the accuracy of PET-CT for the preoperative assessment of lymph node metastasis. The evaluation includes a combination with standard diagnostic tools (endoluminal ultrasound, CT and diagnostic laparoscopy prior to neoadjuvant therapy). Standardized D2-lymphadenectomy is performed and individual lymph node stations (Nr 1-12 according to the Japanese classification) are histopathologically examined. Furthermore we evaluate the role of the PET-CT for early metabolic response evaluation in patients receiving neoadjuvant chemotherapy.\n\n* Trial with surgical intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Histological prove of adenocarcinoma of the stomach.\n\nExclusion criteria:\n\n* Recurrent gastric carcinoma\n* No informed consent\n* Previous malignancy (exception: thyroid, bladder in situ, Cervix in situ)'}, 'identificationModule': {'nctId': 'NCT00800969', 'briefTitle': 'Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'orgStudyIdInfo': {'id': 'VIS-UGI-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'all patients', 'description': 'all patients with Adenocarcinoma', 'interventionNames': ['Procedure: FDG-PET-CT']}], 'interventions': [{'name': 'FDG-PET-CT', 'type': 'PROCEDURE', 'description': 'Radiologic standard procedure', 'armGroupLabels': ['all patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Kuno Lehmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Visceral surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}