|
ISRCTN
|
ISRCTN82375386
|
|
DOI
|
10.1186/ISRCTN82375386
|
|
ClinicalTrials.gov identifier
|
NCT00005586
|
|
EudraCT number
|
|
|
Public title
|
QUASAR (stands for QUick and Simple And Reliable). UKCCCR randomised study of adjuvant chemotherapy in colon and rectal cancer
|
|
Scientific title
|
|
|
Acronym
|
QUASAR
|
|
Serial number at source
|
G9436870/G9521239
|
|
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).
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Colorectal Cancer
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
There are no definite exclusion criteria but patients must be considered fit by their clinicians to undergo six months chemotherapy.
|
|
Anticipated start date
|
01/05/1994
|
|
Anticipated end date
|
31/10/2003
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
5000
|
|
Interventions
|
Chemotherapy versus open control
|
|
Primary outcome measure(s)
|
Survival, recurrence, cost-effectiveness, quality of life.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Medical Research Council
|
|
Trial website
|
|
|
Publications
|
1. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10821362
2. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11038030
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18083404
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21383284
|
|
Contact name
|
Prof
Richard
Gray
|
|
Address
|
University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B15 2RR
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)121 415 9100
|
|
Fax
|
+44 (0)121 687 2313
|
|
Email
|
r.gray@bham.ac.uk
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
06/04/2000
|
|
Last edited
|
04/07/2011
|
|
Date ISRCTN assigned
|
06/04/2000
|
