QUASAR (stands for QUick and Simple And Reliable). UKCCCR randomised study of adjuvant chemotherapy in colon and rectal cancer

ISRCTN	ISRCTN82375386
DOI	https://doi.org/10.1186/ISRCTN82375386
ClinicalTrials.gov number	NCT00005586
Secondary identifying numbers	G9436870/G9521239

Submission date: 06/04/2000
Registration date: 06/04/2000
Last edited: 17/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Richard Gray
Scientific

University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom

Phone	+44 (0)121 415 9100
Email	r.gray@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	QUASAR (stands for QUick and Simple And Reliable). UKCCCR randomised study of adjuvant chemotherapy in colon and rectal cancer
Study acronym	QUASAR
Study hypothesis	Reliable assessment, among patients who have undergone apparently curative surgery for colorectal cancer, of the balance of benefits and risks of adjuvant chemotherapy. Patients for whom there is substantial uncertainty whether or not they should receive chemotherapy are randomised between chemotherapy versus open control. Patients considered to have a clear indication for chemotherapy were randomised (until 1997) between different chemotherapy regimens. Of those who receive adjuvant chemotherapy, the four treatment regimens were: 1. 5-FU (370 mg/m^2) + 175 mg L-folinic acid + levamisole 2. 5-FU (370 mg/m^2) + 175 mg L-folinic acid + placebo 3. 5-FU (370 mg/m^2) + 25 mg L-folinic acid + levamisole 4. 5-FU (370 mg/m^2) + 25 mg L-folinic acid + placebo given either daily for five days every four weeks for a total of six cycles, or once-weekly for thirty weeks. Since 1997 patients allocated chemotherapy all receive arm four (without placebo).
Ethics approval(s)	Not provided at time of registration
Condition	Colorectal Cancer
Intervention	Chemotherapy versus open control
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Chemotherapy: Fluorouracil, L-folinic acid and levamisole
Primary outcome measure	Survival, recurrence, cost-effectiveness, quality of life.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/1994
Overall study end date	31/10/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	5000
Participant inclusion criteria	Patients who have had apparently curative surgery for Duke's A, B or C colorectal cancer within the past three months are eligible for inclusion in QUASAR.
Participant exclusion criteria	There are no definite exclusion criteria but patients must be considered fit by their clinicians to undergo six months chemotherapy.
Recruitment start date	01/05/1994
Recruitment end date	31/10/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Birmingham Clinical Trials Unit

Birmingham
B15 2RR
United Kingdom

Sponsor information

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

Funders

Funder type

Research council

Medical Research Council
Government organisation / National government

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

Results and Publications

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

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Results article	results	06/05/2000	Yes	No
Results article	results	01/08/2000	Yes	No
Results article	results	15/12/2007	Yes	No
Results article	results	01/04/2011	Yes	No

Editorial Notes

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