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