Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
18/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctu.mrc.ac.uk/studies/CR07.asp

Contact information

Type

Scientific

Primary contact

Dr David Sebag-Montefiore

ORCID ID

Contact details

Leeds Cancer Centre
Cookridge Hospital
Hospital Lane
Leeds
LS16 6QB
United Kingdom

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes