A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
2 other identifiers
interventional
326
2 countries
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2001
Longer than P75 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 9, 2013
August 1, 2013
7.9 years
September 2, 2005
August 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local recurrence
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
Secondary Outcomes (4)
Survival
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
Toxicity
Interim analyses will occur annually.
Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection.
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
Quality of life
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
Study Arms (3)
Short Course Radiotherapy
ACTIVE COMPARATORShort Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
Long Course Radiotherapy
ACTIVE COMPARATORLong Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
Surgery
ACTIVE COMPARATORPatients 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.
Interventions
Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles
Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles
25 Gy in 5 fractions over 5 days.
50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.
5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).
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
Eligibility Criteria
You may qualify if:
- All of the following must apply:
- Pathologically documented and clinically resectable adenocarcinoma of the rectum.
- The patient must be considered by the surgeon to be suitable for a curative resection.
- The patient must be considered by the radiation oncologist to have no contraindication to pre-operative radiotherapy.
- 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.
- Tumour with lower border within 12 cm from anal verge on rigid sigmoidoscopy.
- ECOG performance status 0, 1 or 2.
- Adequate bone marrow function with neutrophil count at least 1.5 x 109/L and platelet count at least 100 x 109/L.
- Adequate liver function with bilirubin and alanine aminotransferase (ALT) \<= 1.5 times the upper limit of normal.
- Adequate renal function with serum creatinine \<= 1.5 times the upper limit of normal.
- Accessibility for treatment and follow-up.
- Written informed consent.
You may not qualify if:
- None of the following must apply:
- Evidence of distant metastases.
- Recurrent rectal cancer.
- Unstable cardiac disease or clinically significant active infection.
- Other cancer in the last 5 years except treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.
- 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.
- Prior pelvic or abdominal radiotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, 2560, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Liverpool Hospital
Liverpool, New South Wales, 1871, Australia
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, 2310, Australia
Nepean Cancer Care Centre
Penrith, New South Wales, 2751, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2069, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, 2650, Australia
Westmead Hospital
Wentworthville, New South Wales, 2145, Australia
Mater Private Hospital
Brisbane, Queensland, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Mater QRI
South Brisbane, Queensland, 4101, Australia
North Queensland Oncology Service
Townsville, Queensland, 4810, Australia
East Coast Cancer Centre
Tugun, Queensland, 4224, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Peter MacCallum Cancer Centre
Bendigo, Victoria, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
East Bentleigh, Victoria, 3165, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
St Vincents Melbourne
Fitzroy, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Andrew Love Cancer Centre, Geelong Hospital
Geelong, Victoria, 3220, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3002, Australia
Alfred Hospital
Prahran, Victoria, 3181, Australia
Murray Valley Private Hospital
Wodonga, Victoria, 3690, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Auckland Hospital
Auckland, 1001, New Zealand
Waikato Hospital
Hamilton, 3200, New Zealand
Wellington Hospital
Wellington, 7902, New Zealand
Related Publications (5)
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: 11547717BACKGROUNDFolkesson 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: 16110023BACKGROUNDNgan 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: 15906126BACKGROUNDAnsari 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: 27631775DERIVEDNgan 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.
PMID: 23008301DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sam Ngan, FRANZCR
Peter MacCallum Cancer Centre, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 5, 2005
Study Start
July 1, 2001
Primary Completion
June 1, 2009
Study Completion
May 1, 2011
Last Updated
August 9, 2013
Record last verified: 2013-08