Pathology-guided treatment of rectal cancer

ISRCTN	ISRCTN28785842
DOI	https://doi.org/10.1186/ISRCTN28785842
ClinicalTrials.gov number	NCT00003422
Secondary identifying numbers	CR07

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David Sebag-Montefiore
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Pathology-guided treatment of rectal cancer: a randomised controlled trial
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/02/1998
Completion date	05/08/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1350
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/1998
Date of final enrolment	05/08/2005

Leeds Cancer Centre

Leeds
LS16 6QB
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	Initial results:	07/03/2009	Yes	No
Results article	Prospective study results:	07/03/2009	Yes	No

17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)