Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
A Randomised Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer
5 other identifiers
interventional
1,800
2 countries
9
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving radiation therapy before surgery is more effective than giving chemotherapy plus radiation therapy after surgery in treating patients with rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy given before surgery to see how well it works compared to chemotherapy and radiation therapy given after surgery in treating patients with rectal cancer that can be surgically removed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Jan 1998
Longer than P75 for phase_3 colorectal-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedDecember 4, 2013
March 1, 2007
November 1, 1999
December 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local recurrence by biopsy, imaging, or imaging and carcinoembryonic antigen result
Secondary Outcomes (7)
Local recurrence-free survival
Overall survival
Time to appearance of distant metastases
Disease-free survival
Morbidity
- +2 more secondary outcomes
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Medical Research Councillead
- NCIC Clinical Trials Groupcollaborator
Study Sites (9)
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4, Canada
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, L2R 5K3, Canada
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY, United Kingdom
Related Publications (6)
Stephens RJ, Thompson LC, Quirke P, Steele R, Grieve R, Couture J, Griffiths GO, Sebag-Montefiore D. Impact of short-course preoperative radiotherapy for rectal cancer on patients' quality of life: data from the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 randomized clinical trial. J Clin Oncol. 2010 Sep 20;28(27):4233-9. doi: 10.1200/JCO.2009.26.5264. Epub 2010 Jun 28.
PMID: 20585099RESULTQuirke P, Steele R, Monson J, Grieve R, Khanna S, Couture J, O'Callaghan C, Myint AS, Bessell E, Thompson LC, Parmar M, Stephens RJ, Sebag-Montefiore D; MRC CR07/NCIC-CTG CO16 Trial Investigators; NCRI Colorectal Cancer Study Group. Effect of the plane of surgery achieved on local recurrence in patients with operable rectal cancer: a prospective study using data from the MRC CR07 and NCIC-CTG CO16 randomised clinical trial. Lancet. 2009 Mar 7;373(9666):821-8. doi: 10.1016/S0140-6736(09)60485-2.
PMID: 19269520RESULTSebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0.
PMID: 19269519RESULTQuirke P, Sebag-Montefiore D, Steele R, et al.: Local recurrence after rectal cancer resection is strongly related to the plane of surgical dissection and is further reduced by pre-operative short course radiotherapy. Preliminary results of the Medical Research Council (MRC) CR07 trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-3512, 2006.
RESULTSebag-Montefiore D, Steele R, Quirke P, et al.: Routine short course pre-op radiotherapy or selective post-op chemoradiotherapy for resectable rectal cancer? Preliminary results of the MRC CR07 randomised trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-3511, 2006.
RESULTSebag-Montefiore D: An update report on the MRC CR07 trial. [Abstract] Br J Cancer 85 (suppl 1): A-9.3, 28, 2001.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
R. Steele
Ninewells Hospital
- STUDY CHAIR
Jean Couture, MD
Hopital Charles Lemoyne
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
January 1, 1998
Study Completion
June 1, 2010
Last Updated
December 4, 2013
Record last verified: 2007-03