Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Gray

ORCID ID

Contact details

University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom
+44 (0)121 415 9100
r.gray@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00005586

Protocol/serial number

G9436870/G9521239

Study information

Scientific title

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Colorectal Cancer

Intervention

Chemotherapy versus open control

Intervention type

Drug

Phase

Not Specified

Drug names

Chemotherapy: Fluorouracil, L-folinic acid and levamisole

Primary outcome measures

Survival, recurrence, cost-effectiveness, quality of life.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1994

Overall trial end date

31/10/2003

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

5000

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

United Kingdom

Trial participating centre

University of Birmingham Clinical Trials Unit
Birmingham
B15 2RR
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

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

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

Publication citations

  1. Results

    Comparison of fluorouracil with additional levamisole, higher-dose folinic acid, or both, as adjuvant chemotherapy for colorectal cancer: a randomised trial. QUASAR Collaborative Group., Lancet, 2000, 355, 9215, 1588-1596.

  2. Results

    Kerr DJ, Gray R, McConkey C, Barnwell J, Adjuvant chemotherapy with 5-fluorouracil, L-folinic acid and levamisole for patients with colorectal cancer: non-randomised comparison of weekly versus four-weekly schedules--less pain, same gain. QUASAR Colorectal Cancer Study Group., Ann. Oncol., 2000, 11, 8, 947-955.

  3. Results

    Hutchins G, Southward K, Handley K, Magill L, Beaumont C, Stahlschmidt J, Richman S, Chambers P, Seymour M, Kerr D, Gray R, Quirke P, Value of mismatch repair, KRAS, and BRAF mutations in predicting recurrence and benefits from chemotherapy in colorectal cancer., J. Clin. Oncol., 2011, 29, 10, 1261-1270, doi: 10.1200/JCO.2010.30.1366.

  4. , Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ, Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study., Lancet, 2007, 370, 9604, 2020-2029, doi: 10.1016/S0140-6736(07)61866-2.

Additional files

Editorial Notes