Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00145769
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2005-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
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': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-07', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local recurrence', 'timeFrame': 'Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)'}, {'measure': 'Toxicity', 'timeFrame': 'Interim analyses will occur annually.'}, {'measure': 'Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection.', 'timeFrame': 'Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)'}, {'measure': 'Quality of life', 'timeFrame': 'Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rectal cancer', 'radiotherapy', 'chemotherapy', 'chemoradiation', 'adjuvant therapy'], 'conditions': ['Adenocarcinoma of Rectum']}, 'referencesModule': {'references': [{'pmid': '11547717', 'type': 'BACKGROUND', 'citation': 'Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. doi: 10.1056/NEJMoa010580.'}, {'pmid': '16110023', 'type': 'BACKGROUND', 'citation': 'Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U. Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005 Aug 20;23(24):5644-50. doi: 10.1200/JCO.2005.08.144.'}, {'pmid': '15906126', 'type': 'BACKGROUND', 'citation': 'Ngan SY, Fisher R, Burmeister BH, Mackay J, Goldstein D, Kneebone A, Schache D, Joseph D, McKendrick J, Leong T, McClure B, Rischin D. Promising results of a cooperative group phase II trial of preoperative chemoradiation for locally advanced rectal cancer (TROG 9801). Dis Colon Rectum. 2005 Jul;48(7):1389-96. doi: 10.1007/s10350-005-0032-x.'}, {'pmid': '27631775', 'type': 'DERIVED', 'citation': 'Ansari N, Solomon MJ, Fisher RJ, Mackay J, Burmeister B, Ackland S, Heriot A, Joseph D, McLachlan SA, McClure B, Ngan SY. Acute Adverse Events and Postoperative Complications in a Randomized Trial of Preoperative Short-course Radiotherapy Versus Long-course Chemoradiotherapy for T3 Adenocarcinoma of the Rectum: Trans-Tasman Radiation Oncology Group Trial (TROG 01.04). Ann Surg. 2017 May;265(5):882-888. doi: 10.1097/SLA.0000000000001987.'}, {'pmid': '23008301', 'type': 'DERIVED', 'citation': 'Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, Ackland SP, Schache D, McClure B, McLachlan SA, McKendrick J, Leong T, Hartopeanu C, Zalcberg J, Mackay J. Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04. J Clin Oncol. 2012 Nov 1;30(31):3827-33. doi: 10.1200/JCO.2012.42.9597. Epub 2012 Sep 24.'}], 'seeAlsoLinks': [{'url': 'http://www.trog.com.au', 'label': 'Click here for more information about this study on the TROG official website'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-centre randomised trial comparing long course (LC) preoperative chemoradiation with short course (SC) preoperative radiotherapy for patients with localised T3 rectal cancer.', 'detailedDescription': 'Objective:\n\n* The objective is, in patients with T3 clinically resectable carcinoma of the rectum, to demonstrate that the local recurrence rate in patients treated with a long course (LC) of pre-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course (SC) of pre-operative radiotherapy with early surgery\n\nEligibility Criteria:\n\n* The main eligibility criteria are that the patient has clinically resectable adenocarcinoma of the rectum, a clinical stage T3 tumour whose lower border is within 12 cm of the anal verge, and no evidence of distant metastases.\n\nEndpoints:\n\n* Primary endpoint is local recurrence.\n* Secondary endpoints are overall survival, toxicity, abdminoperineal resection rate, quality of life.\n\nTreatment arms:\n\n* SC arm: Radiotherapy (RT) 25 Gy in 5 fr in 1 week to be followed by surgery within 1 week and 6 cycles of postoperative chemotherapy 5FU/Folinic acid.\n* LC arm: RT 50.4 Gy in 28 fr in 5½weeks with 5FU 225 mg/m2/day throughout the course of RT, to be followed by surgery 4-6 weeks after completion of RT. 4 cycles of adjuvant 5FU/Folinic acid will be given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll of the following must apply:\n\n* Pathologically documented and clinically resectable adenocarcinoma of the rectum.\n* The patient must be considered by the surgeon to be suitable for a curative resection.\n* The patient must be considered by the radiation oncologist to have no contraindication to pre-operative radiotherapy.\n* Clinical T3 stage tumour on endorectal ultrasound or MRI. When endorectal ultrasound cannot be performed satisfactorily due to a technical reason, such as stenosis or proximity of the tumour, and MRI is not available, infiltration of perirectal fat on CT scan is also acceptable.\n* Tumour with lower border within 12 cm from anal verge on rigid sigmoidoscopy.\n* ECOG performance status 0, 1 or 2.\n* Adequate bone marrow function with neutrophil count at least 1.5 x 109/L and platelet count at least 100 x 109/L.\n* Adequate liver function with bilirubin and alanine aminotransferase (ALT) \\<= 1.5 times the upper limit of normal.\n* Adequate renal function with serum creatinine \\<= 1.5 times the upper limit of normal.\n* Accessibility for treatment and follow-up.\n* Written informed consent.\n\nExclusion Criteria:\n\n* None of the following must apply:\n* Evidence of distant metastases.\n* Recurrent rectal cancer.\n* Unstable cardiac disease or clinically significant active infection.\n* Other cancer in the last 5 years except treated non-melanoma skin cancer or carcinoma in situ of the cervix.\n* Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.\n* Contraindication to insertion of a suitable indwelling venous catheter e.g. implantable central venous device (infuse-a-port), Hickman catheter or peripherally inserted central catheter.\n* Prior pelvic or abdominal radiotherapy.'}, 'identificationModule': {'nctId': 'NCT00145769', 'briefTitle': 'A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum', 'organization': {'class': 'OTHER', 'fullName': 'Trans Tasman Radiation Oncology Group'}, 'officialTitle': 'A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum', 'orgStudyIdInfo': {'id': 'TROG 01.04'}, 'secondaryIdInfos': [{'id': 'NHMRC 209123', 'type': 'OTHER_GRANT', 'domain': 'National Health Medical and Research Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short Course Radiotherapy', 'description': 'Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy', 'interventionNames': ['Drug: Short Course Adjuvent Chemotherapy', 'Radiation: Short Course Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long Course Radiotherapy', 'description': 'Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy', 'interventionNames': ['Drug: Long Course Adjuvant Chemotherapy', 'Radiation: Long Course Radiotherapy', 'Drug: Concurrent Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'description': 'Patients will receive initial surgery followed by post-operative management according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Adjuvant therapy for rectal cancer.', 'interventionNames': ['Procedure: Initial Surgery']}], 'interventions': [{'name': 'Short Course Adjuvent Chemotherapy', 'type': 'DRUG', 'description': 'Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles', 'armGroupLabels': ['Short Course Radiotherapy']}, {'name': 'Long Course Adjuvant Chemotherapy', 'type': 'DRUG', 'description': 'Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles', 'armGroupLabels': ['Long Course Radiotherapy']}, {'name': 'Short Course Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Radiation', 'RT', 'Short Course'], 'description': '25 Gy in 5 fractions over 5 days.', 'armGroupLabels': ['Short Course Radiotherapy']}, {'name': 'Long Course Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Radiation', 'RT', 'Long Course'], 'description': '50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.', 'armGroupLabels': ['Long Course Radiotherapy']}, {'name': 'Concurrent Chemotherapy', 'type': 'DRUG', 'description': '5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).', 'armGroupLabels': ['Long Course Radiotherapy']}, {'name': 'Initial Surgery', 'type': 'PROCEDURE', 'description': 'Surgery is to be performed according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Elective surgery for rectal cancer', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Garran', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'The Canberra Hospital', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '2560', 'city': 'Campbelltown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Macarthur Cancer Therapy Centre', 'geoPoint': {'lat': -34.06667, 'lon': 150.81667}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '1871', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2310', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Newcastle Mater Misericordiae Hospital', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2751', 'city': 'Penrith', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Nepean Cancer Care Centre', 'geoPoint': {'lat': -33.75, 'lon': 150.7}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2069', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2650', 'city': 'Wagga Wagga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Riverina Cancer Care Centre', 'geoPoint': {'lat': -35.12577, 'lon': 147.35375}}, {'zip': '2145', 'city': 'Wentworthville', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80652, 'lon': 150.96785}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Mater Private Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane Hospital', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Mater QRI', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '4810', 'city': 'Townsville', 'state': 'Queensland', 'country': 'Australia', 'facility': 'North Queensland Oncology Service', 'geoPoint': {'lat': -19.26639, 'lon': 146.80569}}, {'zip': '4224', 'city': 'Tugun', 'state': 'Queensland', 'country': 'Australia', 'facility': 'East Coast Cancer Centre', 'geoPoint': {'lat': -28.15, 'lon': 153.5}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '7250', 'city': 'Launceston', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Launceston General Hospital', 'geoPoint': {'lat': -41.43876, 'lon': 147.13467}}, {'city': 'Bendigo', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -36.75818, 'lon': 144.28024}}, {'city': 'Box Hill', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Box Hill Hospital', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '3165', 'city': 'East Bentleigh', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre'}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'St Vincents Melbourne', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'city': 'Footscray', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Western Hospital', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Frankston Hospital', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Andrew Love Cancer Centre, Geelong Hospital', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3181', 'city': 'Prahran', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.85114, 'lon': 144.99318}}, {'zip': '3690', 'city': 'Wodonga', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Murray Valley Private Hospital', 'geoPoint': {'lat': -36.12179, 'lon': 146.88809}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '1001', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '3200', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '7902', 'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Wellington Hospital', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'overallOfficials': [{'name': 'Sam Ngan, FRANZCR', 'role': 'STUDY_CHAIR', 'affiliation': 'Peter MacCallum Cancer Centre, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trans Tasman Radiation Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Australasian Gastro-Intestinal Trials Group', 'class': 'NETWORK'}, {'name': 'Colorectal Surgical Society of Australasia (CSSA)', 'class': 'UNKNOWN'}, {'name': 'Royal Australasian College of Surgeons (RACS)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}