Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT01702116
Status:
UNKNOWN
Last Update Posted:
2013-04-25
First Post:
2011-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-23', 'studyFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of circumferential resection margin', 'timeFrame': '0-10 minutes post surgery', 'description': 'Measurement in millimeters (mm) of the circumferential resection margin.'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': '4-6 hours', 'description': 'operative time from skin incision to skin closure'}, {'measure': 'hospital stay', 'timeFrame': 'from beginning of surgery through discharge, usually 4-5 days', 'description': 'duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)'}, {'measure': 'estimated blood loss', 'timeFrame': '4-6 hours', 'description': 'estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rectal adenocarcinoma', 'Standard APR', 'Extralevator APR'], 'conditions': ['Rectal Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '27369739', 'type': 'DERIVED', 'citation': 'Bianco F, Romano G, Tsarkov P, Stanojevic G, Shroyer K, Giuratrabocchetta S, Bergamaschi R; International Rectal Cancer Study Group. Extralevator with vs nonextralevator abdominoperineal excision for rectal cancer: the RELAPe randomized controlled trial. Colorectal Dis. 2017 Feb;19(2):148-157. doi: 10.1111/codi.13436.'}]}, 'descriptionModule': {'briefSummary': 'This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. The investigators are doing this research to see whether the extralevator APR increases the likelihood that the edge of the tissue that is removed will be more likely to be free from cancer cells compared with the conventional APR surgery. At this time there is no evidence that one type of procedure is better at this than the other. The objective of this research is to determine whether extralevator APR is more likely to have clean margins (free of cancer) compared to the standard APR surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation:\n* Stage T3 or T4 at MRI\n* N0-2 at MRI\n* M0 at CT scan\n* Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents\n\nExclusion Criteria:\n\n* Squamous cell carcinoma\n* Adenocarcinoma Stage T1-2, any N\n* T4 with one of the following:\n\nwith pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy'}, 'identificationModule': {'nctId': 'NCT01702116', 'briefTitle': 'Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'APR2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extralevator APR', 'description': 'This is a modified and more extensive procedure that is used to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.', 'interventionNames': ['Procedure: extralevator APR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard APR', 'description': 'conventional abdominoperineal resection (APR)', 'interventionNames': ['Procedure: APR']}], 'interventions': [{'name': 'extralevator APR', 'type': 'PROCEDURE', 'description': 'Extralevator Abdominoperineal Resection For Rectal Adenocarcinoma. The aim of this modified and more extensive procedure is to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.', 'armGroupLabels': ['extralevator APR']}, {'name': 'APR', 'type': 'PROCEDURE', 'description': 'standard Abdominoperineal Resection For Rectal Adenocarcinoma', 'armGroupLabels': ['standard APR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794-8191', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roberto Bergamaschi, MD, PhD', 'role': 'CONTACT', 'email': 'rbergamaschi@notes.cc.sunysb.edu', 'phone': '631-444-2704'}, {'name': 'Paula Denoya, MD', 'role': 'CONTACT', 'email': 'pdenoya@notes.cc.sunysb.edu', 'phone': '631-444-3431'}, {'name': 'Paula Denoya, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'State University Hospital Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '11794-8191', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roberto Bergamaschi, MD, PhD', 'role': 'CONTACT', 'email': 'rbergamaschi@notes.cc.sunysb.edu', 'phone': '631-444-2704'}, {'name': 'Paula Denoya, MD', 'role': 'CONTACT', 'email': 'pdenoya@notes.cc.sunysb.edu', 'phone': '631-444-3431'}, {'name': 'Paula Denoya, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kenneth Shroyer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stony Broook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roberto Bergamaschi, MD, PhD', 'role': 'CONTACT', 'email': 'rbergamaschi@notes.cc.sunysb.edu', 'phone': '631-444-2704'}, {'name': 'Roberto Bergamaschi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paula Denoya, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sami Khan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meenakshi Singh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kenneth Shroyer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roberto Bergamaschi, MD, PhD', 'role': 'CONTACT', 'email': 'rbergamaschi@notes.cc.sunysb.edu', 'phone': '631-444-2704'}, {'name': 'Roberto Bergamaschi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paula Denoya, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sami Khan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meenakshi Singh, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'centralContacts': [{'name': 'Roberto Bergamaschi, MD, PhD', 'role': 'CONTACT', 'email': 'rbergamaschi@notes.cc.sunysb.edu', 'phone': '631-444-2704'}, {'name': 'Eileen Finnin, RN', 'role': 'CONTACT', 'email': 'efinnin@notes.cc.sunysb.edu', 'phone': '631-444-5454'}], 'overallOfficials': [{'name': 'Roberto Bergamaschi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chief, Colon and Rectal Surgery', 'investigatorFullName': 'Roberto Bergamaschi', 'investigatorAffiliation': 'Stony Brook University'}}}}