Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-01-03 @ 7:58 PM
Study NCT ID:
NCT02406118
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '2-year local recurrence free survival', 'timeFrame': '2 years after surgery'}, {'measure': '5-year overall survival', 'timeFrame': '5 years after surgery'}], 'primaryOutcomes': [{'measure': 'TME quality & circumferential resection margin (CRM)', 'timeFrame': 'the day of trananal TME', 'description': 'The quality of the mesorectum was determined using pathology reports and scored using three grades:\n\n* Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.\n* Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.\n* Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.'}], 'secondaryOutcomes': [{'measure': '30-day postoperative complications', 'timeFrame': '1 month after surgery'}, {'measure': 'Number of harvested Lymph Nodes', 'timeFrame': 'the day of surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transanal TME quality', 'CRM'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '29624549', 'type': 'DERIVED', 'citation': 'Park SC, Sohn DK, Kim MJ, Chang HJ, Han KS, Hyun JH, Joo J, Oh JH. Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.', 'detailedDescription': 'Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age: 20-80 years\n2. biopsy-proven adenocarcinoma of the rectum\n3. clinical staging (c or yc): T0-3, N0-2, M0\n4. Rectal cancer located 3-12 cm from the anal verge\n5. ECOG performance status: 2 or less\n6. BMI: less than 30\n\nExclusion Criteria:\n\n1. Synchronous colon cancer or other malignancy\n2. Obstructing rectal cancer\n3. Pregnant or breast-feeding\n4. Receiving any other study agents\n5. Fecal incontinence\n6. History of prior colorectal cancer or inflammatory bowel disease\n7. Tumor size: more than 7cm in long diameter\n8. CRM: mesorectal fascia involvement or less than 1 mm on MRI'}, 'identificationModule': {'nctId': 'NCT02406118', 'briefTitle': 'Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision', 'orgStudyIdInfo': {'id': 'NCC2015-0033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transanal total mesorectal excision', 'description': 'Laparoscopy-assisted transanal total mesorectal excision', 'interventionNames': ['Procedure: Transanal total mesorectal excision']}], 'interventions': [{'name': 'Transanal total mesorectal excision', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopy-assisted transanal TME'], 'description': 'Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.', 'armGroupLabels': ['Transanal total mesorectal excision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'Dae Kyung Sohn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCC,Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD., PHD, Center for Colorectal Cancer', 'investigatorFullName': 'Dae Kyung Sohn', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}