Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
30/07/2009
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

Dr Dionne Cain

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CR06

Study information

Scientific title

Acronym

Study hypothesis

This 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Colorectal cancer

Intervention

Patients 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 type

Drug

Phase

Not Specified

Drug names

fluorouracil, leucovorin calcium, raltitrexed

Primary outcome measures

Survival

Secondary outcome measures

Quality 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 trial start date

10/05/1996

Overall trial end date

10/05/1999

Reason abandoned

Eligibility

Participant inclusion criteria

First 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

First randomisation = 905, second randomisation = 354

Participant exclusion criteria

Exclusion 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

Recruitment start date

10/05/1996

Recruitment end date

10/05/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
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 (MRC) (UK)

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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12583944

Publication citations

  1. Results

    Maughan TS, James RD, Kerr DJ, Ledermann JA, Seymour MT, Topham C, McArdle C, Cain D, Stephens RJ, , Comparison of intermittent and continuous palliative chemotherapy for advanced colorectal cancer: a multicentre randomised trial., Lancet, 2003, 361, 9356, 457-464.

Additional files

Editorial Notes