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 measure
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 (if study stopped)
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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
Basic results (scientific)
Publication list
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12583944
Publication citations
-
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.