Chemotherapy choices in advanced colorectal cancer - a randomised trial comparing two durations and three chemotherapy regimens in the palliative treatment of advanced colorectal cancer

ISRCTN ISRCTN82942120
DOI https://doi.org/10.1186/ISRCTN82942120
Secondary identifying numbers CR06
Submission date
06/04/2000
Registration date
06/04/2000
Last edited
30/07/2009
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 of protocol

Not provided at time of registration

Contact information

Dr Dionne Cain
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesThis trial aims to address two questions in the palliative treatment of patients with advanced colorectal cancer, namely:
1. Are the three chemotherapy regimens equivalent in terms of survival, and if so are there differences in the levels of quality of life (QoL) experienced by the patients?
2. In patients with stable or responding disease at 12 weeks, is there a survival benefit if chemotherapy is continued indefinitely, compared to a policy of stopping chemotherapy at 12 weeks, and what are the quality of life implications?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedColorectal cancer
InterventionPatients with advanced colorectal cancer are randomised between three groups:
1. De Gramont bolus and infusion 5FU and folinic acid regimen
2. Lokich continuous infusion 5FU regimen
3. 'Tomudex' iv bolus.

After 12 weeks their status is reassessed and those patients with responding or stable disease are randomised to one of two groups:
1. STOP chemotherapy, retreating on progression if appropriate
2. CONTINUE chemotherapy, with 12-weekly review, until disease progression, or unacceptable toxicity
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)fluorouracil, leucovorin calcium, raltitrexed
Primary outcome measureSurvival
Secondary outcome measuresQuality of life, palliation of symptoms, toxicity, psychological impact, functional status, social functioning, global quality of life, subsidiary response rate health economics acceptability of treatment to patients
Overall study start date10/05/1996
Completion date10/05/1999

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsFirst randomisation = 905, second randomisation = 354
Key inclusion criteriaFirst randomisation inclusion:
1. Histologically confirmed adenocarcinoma of the colon or rectum
2. Patients with either: locally advanced disease at presentation suitable only for palliative chemotherapy; metastatic disease at presentation suitable only for palliative chemotherapy; recurrent locally advanced or metastatic disease, now only suitable for palliative chemotherapy. If systemic chemotherapy was given previously this must have been 5-Flurouracil (5FU) based adjuvant therapy (eg QUASAR) and completed more than six months prior to trial entry. Disease not limited to a previously irradiated area.
3. Objectively or subjectively evaluable disease
4. Adequate bone marrow function
5. Adequate renal function with serum creatinine 1.25 x upper limit of normal and creatinine clearance more than 65 ml if serum creatinine exceeds upper limit of normal
6. World Health Organisation (WHO) performance status of 0 - 2, with life expectancy more than three months
7. Patient able and willing to complete QoL questionnaires

Second randomisation: All patients in the trial should be randomised to stop or continue chemotherapy after 12 weeks (see 'Exclusions' below for exceptions)
Key exclusion criteriaExclusion for second randomisation:
1. Patients with progressive disease on clinical or radiological evidence (more than a 25% increase in size of an existing lesion, or new lesions), or death
2. Patients who have stopped chemotherapy because of toxicity
3. Patient choice
Date of first enrolment10/05/1996
Date of final enrolment10/05/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
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 (MRC) (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/02/2003 Yes No