Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
NCT ID: NCT00003422
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1800 participants
INTERVENTIONAL
1998-01-31
2010-06-30
Brief Summary
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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.
Detailed Description
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* Compare local recurrence free rates and quality of life in patients with operable rectal cancer receiving preoperative radiotherapy versus patients receiving selective postoperative chemoradiotherapy.
* Determine local recurrence free survival, overall survival, time to appearance of distant metastases, disease free survival and morbidity in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by a number of factors including surgeon.
Patients are randomized to receive preoperative radiotherapy (arm I) or postoperative chemoradiotherapy (arm II).
* Arm I: Patients receive radiotherapy in 5 fractions over 1 week prior to surgery. Patients undergo surgery within 7 days of the last fraction of radiotherapy.
* Arm II: Patients receive chemoradiotherapy 4-12 weeks after surgery (if circumferential resection margins are histologically involved by tumor). Radiotherapy is administered in 25 fractions over 5 weeks (5 days per week). During radiotherapy, patients either receive fluorouracil (5-FU) continuous infusion, 5-FU bolus IV and leucovorin calcium IV weekly, or a 5-day bolus schedule of 5-FU and leucovorin calcium.
Patients may then receive adjuvant chemotherapy as per local policy.
Quality of life assessments are made every 3 months for 1 year and then every 6 months for the next 2 years.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1800 patients will be accrued into this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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fluorouracil
leucovorin calcium
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the rectum (defined as lower edge of tumor within 15 cm of anal verge)
* Tumor considered potentially operable
* No evidence of metastases indicated by liver ultrasound or CT scan; chest x-ray; or renal, liver, and bone profiles
PATIENT CHARACTERISTICS:
Age:
* 75 and under
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* No uncontrolled heart failure or angina
Other:
* No other concurrent uncontrolled medical illness (e.g., infection)
* No other prior or concurrent malignancy likely to interfere with the protocol treatments or comparisons
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
75 Years
ALL
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
Medical Research Council
OTHER_GOV
Principal Investigators
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R. Steele
Role: STUDY_CHAIR
Ninewells Hospital
Jean Couture, MD
Role: STUDY_CHAIR
Hopital Charles Lemoyne
Locations
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Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Countries
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References
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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.
Quirke 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.
Sebag-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.
Quirke 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.
Sebag-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.
Sebag-Montefiore D: An update report on the MRC CR07 trial. [Abstract] Br J Cancer 85 (suppl 1): A-9.3, 28, 2001.
Other Identifiers
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MRC-CR07
Identifier Type: -
Identifier Source: secondary_id
EU-98008
Identifier Type: -
Identifier Source: secondary_id
CAN-NCIC-C016
Identifier Type: -
Identifier Source: secondary_id
ISRCTN28785842
Identifier Type: -
Identifier Source: secondary_id
CDR0000066442
Identifier Type: -
Identifier Source: org_study_id