TROG 01.04 / IG0103R

A randomised trial of preoperative radiotherapy for stage T3 adenocarcinoma of rectum.

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Trial Status

Completed

Cancer Type

Colorectal Cancer

Aim

A treatment program with preoperative radiotherapy, surgery, and chemotherapy has become the standard of care for locally advanced rectal cancer. Both short course and long course preoperative radiotherapy have been shown to be effective, and have been adopted as standard treatment in different countries. Various cancer centres in Australia have also adopted either short course or long course as their standard of care. However, which form of treatment is better is not known.

The aims of this trial were to compare tumour control, toxicity and quality of life of short course and long course preoperative radiotherapy. Eligible patients were those with ultrasound- or MRI-staged T3 adenocarcinoma of rectum within 12 cm of the anal verge and with no evidence of metastasis. Patients were randomly assigned to either 1 week of radiotherapy followed by surgery the next week and 6 courses of postoperative chemotherapy, or five and half weeks of chemo-radiotherapy followed by surgery in 4 to 6 weeks and 4 courses of postoperative chemotherapy.

Summary

Results on early adverse events were presented at ECCO14 in Barcelona, Spain in September 2007. Analysis of the early quality of life data will be presented at ASCO in Chicago, USA in June 2008. The final analysis will be performed 3 years after the close of accrual.

Trial Status

Completed

Cancer Type

Colorectal Cancer

Publication Reference

  1. McLachlan SA, Fisher RJ, Zalcberg J, Solomon M, Burmeister B, Goldstein D, Leong T, Ackland SP, McKendrick J, McClure B, Mackay J, Ngan SY. The impact on health-related quality of life in the first 12 months: A randomised comparison of preoperative short-course radiation versus long-course chemoradiation for T3 rectal cancer (Trans-Tasman Radiation Oncology Group Trial 01.04). European Journal of Cancer 2016; 55: 15–26.
  2. 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. Journal of Clinical Oncology 2012; 30(31): 3827–3833.

Conference Presentation Reference

  1. Ngan S, Fisher R, Goldstein D, Solomon M, Burmeister B, Ackland SP, Joseph DJ, McClure B, McLachlan SA, Mackay J. A randomized trial comparing local recurrence rates between short-course and long-course preoperative radiotherapy for clinical T3 rectal cancer: an intergroup trial (TROG, AGITG, CSSA, RACS). American Society of Clinical Oncology Annual Meeting; 4–8 Jun 2010; Chicago.
  2. Ngan SY, McLachlan SA, Fisher R, Burmeister B, Joseph D, Hruby G, Ackland S, Ganju V, Mackay J, Solomon M. A comparison of quality of life in patients with rectal cancer receiving short course versus long course preoperative radiation. A Trans-Tasman Radiation Oncology Group, Australasian Gastrointestinal Trials Group, Colorectal Surgical Society of Australia and New Zealand, and Royal Australasian College of Surgeons trial. Royal Australian and New Zealand College of Radiologists 59th Annual Scientific Meeting; 16–19 Oct 2008; Adelaide.
  3. Ngan S, Fisher R, Mackay J, Solomon M, Burmeister B, Goldstein D, Schache D, Joseph D, Ackland S, McClure B. Acute adverse events in a randomised trial of short course versus long course preoperative radiotherapy for T3 adenocarcinoma of rectum: a Trans-Tasman Radiation Oncology Group trial (TROG 01.04). 14th European Cancer Conference (ECCO); 23-27 Sep 2007; Barcelona.
  4. Ngan S, Burmeister B, Fisher R, Joseph D, Solomon M, Schache D, Mackay J, Ackland S, Goldstein D, McClure B, McLachlan S, Dhillon H, Thompson P. A randomised trial of preoperative radiotherapy for stage T3 adenocarcinoma of the rectum (TROG 01.04): a progress report. International Conference on Radiation Research (ICRR); 17-22 Aug 2003; Brisbane.
  5. Burmeister B, Smithers B, Fitzgerald L, Gebski V, Devitt P, Ackland S, Joseph D, Millar J, North J, Walpole E, Denham J. A randomized phase III trial of preoperative chemoradiation followed by surgery versus surgery alone for localized resectable cancer of the esophagus. American Society of Clinical Oncology Annual Meeting; 18–21 May 2002; Orlando.

Aim

A treatment program with preoperative radiotherapy, surgery, and chemotherapy has become the standard of care for locally advanced rectal cancer. Both short course and long course preoperative radiotherapy have been shown to be effective, and have been adopted as standard treatment in different countries. Various cancer centres in Australia have also adopted either short course or long course as their standard of care. However, which form of treatment is better is not known.

The aims of this trial were to compare tumour control, toxicity and quality of life of short course and long course preoperative radiotherapy. Eligible patients were those with ultrasound- or MRI-staged T3 adenocarcinoma of rectum within 12 cm of the anal verge and with no evidence of metastasis. Patients were randomly assigned to either 1 week of radiotherapy followed by surgery the next week and 6 courses of postoperative chemotherapy, or five and half weeks of chemo-radiotherapy followed by surgery in 4 to 6 weeks and 4 courses of postoperative chemotherapy.

Summary

Results on early adverse events were presented at ECCO14 in Barcelona, Spain in September 2007. Analysis of the early quality of life data will be presented at ASCO in Chicago, USA in June 2008. The final analysis will be performed 3 years after the close of accrual.

Principal Investigator

Associate Professor Sam Ngan, Radiation Oncologist, Peter MacCallum Cancer Centre VIC

Collaboration Groups

Trans-Tasman Radiation Oncology Group
Australasian Gastrointestinal Trials Group
Colorectal Surgical Society of Australia and New Zealand
Royal Australasian College of Surgeons

Funding

National Health and Medical Research Council (209123)
Cancer Council Victoria
Royal Australia and New Zealand College of Radiologists