Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-02 @ 10:08 AM
Study NCT ID:
NCT01444495
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2011-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-09-29', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local and systemic recurrence rate', 'timeFrame': '5 years', 'description': 'Rate of local and sytemic recurrences in patients included to the protocol.'}], 'secondaryOutcomes': [{'measure': 'radical resections rate (R0)', 'timeFrame': '1 month', 'description': 'Rate of R0, R1 and R2 procedures according to Hermanek.'}, {'measure': 'sphincter saving (sparing) procedures', 'timeFrame': '1 month', 'description': 'Rate of sphincter saving operations in both arms.'}, {'measure': 'overall survival', 'timeFrame': '5 years', 'description': 'Overall survival and disease specific survival at 5 years follow-up'}, {'measure': 'downstaging of rectal cancer', 'timeFrame': '1 month', 'description': 'Downstaging of the rectal cancer after preoprearite radiotherapy - assessed by comparison of preoperative ERUS, 3D ERUS, contrast enhanced ERUS and postoperative histologic staging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal cancer', 'radiotherapy', 'overall survival', 'recurrence rate', 'downstaging'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '22170083', 'type': 'RESULT', 'citation': 'Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer--treatment results at 5-year follow-up. Langenbecks Arch Surg. 2012 Jun;397(5):801-7. doi: 10.1007/s00423-011-0890-8. Epub 2011 Dec 15.'}, {'pmid': '22398435', 'type': 'RESULT', 'citation': 'Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Erratum to: Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer-treatment results at 5 year follow-up. Langenbecks Arch Surg. 2019 Sep;404(Suppl 1):19-20. doi: 10.1007/s00423-012-0940-x. No abstract available.'}, {'pmid': '34653526', 'type': 'RESULT', 'citation': 'Pach R, Sierzega M, Szczepanik A, Popiela T, Richter P. Preoperative radiotherapy 5 x 5 Gy and short versus long interval between surgery for resectable rectal cancer: 10-Year follow-up of the randomised controlled trial. Radiother Oncol. 2021 Nov;164:268-274. doi: 10.1016/j.radonc.2021.10.006. Epub 2021 Oct 13.'}, {'pmid': '34202691', 'type': 'RESULT', 'citation': 'Pach R, Richter P, Sierzega M, Papp N, Szczepanik A. Preoperative Short-Course Radiotherapy and Surgery versus Surgery Alone for Patients with Rectal Cancer: A Propensity Score-Matched Analysis at 18-Year Follow-Up. Biomedicines. 2021 Jun 24;9(7):725. doi: 10.3390/biomedicines9070725.'}, {'pmid': '35788774', 'type': 'RESULT', 'citation': 'Pach R, Szczepanik AM, Sierzega M, Daniluk M, Richter P. Prognostic value of lymph node ratio in resectable rectal cancer after preoperative short-course radiotherapy-results from randomized clinical trial. Langenbecks Arch Surg. 2022 Nov;407(7):2969-2980. doi: 10.1007/s00423-022-02603-8. Epub 2022 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.', 'detailedDescription': 'The treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on survival has been systematically collected using national census registry. Patients are qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the tumor before and after preoperative radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* histologically confirmed rectal cancer\n* tumor localised in middle or lower rectum\n* age \\> 18 years\n* locally advanced cancer\n\nExclusion Criteria:\n\n* previous pelvis radiotherapy\n* lack of patient's consent\n* lack of possibility to begin radiotherapy during 14 days after inclusion to the study"}, 'identificationModule': {'nctId': 'NCT01444495', 'briefTitle': 'Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer', 'orgStudyIdInfo': {'id': 'Cracow Rectal Cancer Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short time interval', 'description': 'Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.', 'interventionNames': ['Radiation: Preoperative radiotherapy', 'Procedure: Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Long time interval', 'description': 'Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.', 'interventionNames': ['Radiation: Preoperative radiotherapy', 'Procedure: Surgery']}], 'interventions': [{'name': 'Preoperative radiotherapy', 'type': 'RADIATION', 'otherNames': ['Neoadjuvant radiotherapy'], 'description': 'Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)', 'armGroupLabels': ['Long time interval', 'Short time interval']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'otherNames': ['Operative treatment'], 'description': 'Total mesorectal excision of rectal cancer', 'armGroupLabels': ['Long time interval', 'Short time interval']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-501', 'city': 'Krakow', 'state': 'Malopolska', 'country': 'Poland', 'facility': 'First Department of Surgery', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Jan Kulig, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'First Department of General Surgery, Jagiellonian University'}, {'name': 'Radoslaw Pach, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Department of General Surgery, Jagiellonian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor', 'investigatorFullName': 'Radoslaw Pach, MD, PhD', 'investigatorAffiliation': 'Jagiellonian University'}}}}