Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003422
Protocol/serial number
CR07
Study information
Scientific title
Pathology-guided treatment of rectal cancer: a randomised controlled trial
Acronym
Study hypothesis
In inoperable rectal cancer: are local recurrence-free survival rates and quality of life optimised by giving all patients short course pre-operative radiotherapy, or is it a preferable option to give post-operative chemoradiotherapy only to those at high risk of recurrence (i.e. with involved margins following surgery)?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Rectal cancer
Intervention
1. One group receives a short course pre-operative radiotherapy followed by surgery
2. The other group receives surgery followed by postoperative chemo-radiotherapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Local recurrence (as defined using an algorithm designed for the trial).
Secondary outcome measures
1. Local recurrence-free survival
2. Overall survival
3. Time to appearance of distant metastases
4. Disease-free survival
5. Morbidity
6. Quality of life
7. Economic implications
Overall trial start date
01/02/1998
Overall trial end date
05/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed adenocarcinoma of the rectum
2. Considered potentially operable
3. No evidence of metastases
4. Patient considered fit to receive either arm of the trial
5. No concurrent uncontrolled medical illness
6. No previous or current malignant disease likely to interfere with treatment or comparisons
7. Informed consent obtained
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1350
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/1998
Recruitment end date
05/08/2005
Locations
Countries of recruitment
Canada, United Kingdom
Trial participating centre
Leeds Cancer Centre
Leeds
LS16 6QB
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in:
1. Initial results: http://www.ncbi.nlm.nih.gov/pubmed/19269519
2. Prospective study results: http://www.ncbi.nlm.nih.gov/pubmed/19269520
Publication citations
-
Initial results
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, 373, 9666, 811-820, doi: 10.1016/S0140-6736(09)60484-0.
-
Prospective study results
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, , , 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, 373, 9666, 821-828, doi: 10.1016/S0140-6736(09)60485-2.