Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-08 @ 6:59 PM
Study NCT ID:
NCT03393234
Status:
UNKNOWN
Last Update Posted:
2018-01-08
First Post:
2018-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "Patients will be assigned to two different groups and receive intraoperative radiation randomly. The care provider and investigator also don't know the concrete situation of the patients."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2018-01-01', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease free survival', 'timeFrame': '3 years', 'description': 'Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.'}], 'secondaryOutcomes': [{'measure': 'local recurrence rate', 'timeFrame': '1 years', 'description': 'In our study, no matter whether distant metastases occurred, if there was the presence of any anastomotic, pelvic, or lateral node recurrences recorded by pathologic or clinical examination, we defined it as local recurrence.'}, {'measure': 'R0 resection rate', 'timeFrame': '1 years', 'description': 'To calculate the radical resection rate.'}, {'measure': 'sphincter muscle function', 'timeFrame': '1 years', 'description': 'Indicated by the anorectal manometry'}, {'measure': 'anorectal manometry', 'timeFrame': '1 years', 'description': 'To measure the anus pressure to indirectly reflect the sphincter muscle function'}, {'measure': 'predictive biomarkers', 'timeFrame': '3 years', 'description': 'Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.'}, {'measure': 'sexual function', 'timeFrame': '1 years', 'description': 'Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultra-low rectal cancer', 'Intersphincteric resection', 'IORT'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '29981575', 'type': 'DERIVED', 'citation': 'Wang M, Xue W, Zhao Z, Li Y, Wang X, Li T, Zou Y, Song X, Zhang M, Wang T, Yang J, Wang C, Wang S. Laparoscopic intersphincteric resection with intraoperative radiotherapy using low-energy X-rays for locally advanced ultra-low rectal cancer. World J Surg Oncol. 2018 Jul 7;16(1):133. doi: 10.1186/s12957-018-1430-6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.', 'detailedDescription': 'Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients whose diagnosed with clinical stages T1-2 and N0\\_1, which only a few patients with early stages can benefit from it. However, intra-operative radiotherapy with low energy X ray applied by Intrabeam is becoming an accepted radiotherapy technique for treatment of cancers. The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;\n* the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;\n* in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;\n* those in T4 stage and could be radically resected by intra-operative surgeon assessment;\n* adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.\n* absence of distant metastases.\n\nExclusion Criteria:\n\n* clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):\n* infiltrating gross appearance of the tumors;\n* poorly differentiated adenocarcinoma by biopsy specimens;\n* a degree of preoperative incontinence.'}, 'identificationModule': {'nctId': 'NCT03393234', 'acronym': 'IDAVON', 'briefTitle': 'Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Jilin University'}, 'officialTitle': 'Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer', 'orgStudyIdInfo': {'id': 'ISR and IORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A group', 'description': 'Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray.', 'interventionNames': ['Radiation: Interoperative radiation by INTRABEAM using low energy X-ray']}, {'type': 'NO_INTERVENTION', 'label': 'B group', 'description': 'Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.'}], 'interventions': [{'name': 'Interoperative radiation by INTRABEAM using low energy X-ray', 'type': 'RADIATION', 'description': 'Intrabeam is a mobile Platform for Intraoperative Radiotherapy (IORT) produced by the ZEISS company in Germany.Interoperative radiation by INTRABEAM using low energy X-ray.The Intrabeam PRS appears to be a safe technique for delivering IORT in rectal cancer patients.', 'armGroupLabels': ['A group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Wang, M.D.', 'role': 'CONTACT', 'email': 'jdeywangmin@163.com', 'phone': '+86 13074373336'}], 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Min Wang, M.D.', 'role': 'CONTACT', 'email': 'jdeywangmin@163.com', 'phone': '(+86)13074373336'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES', 'description': 'When the investigators complete the study and publish our data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}