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ISRCTN
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ISRCTN82942120
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DOI
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10.1186/ISRCTN82942120
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Chemotherapy choices in advanced colorectal cancer - a randomised trial comparing two durations and three chemotherapy regimens in the palliative treatment of advanced colorectal cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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CR06
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Study hypothesis
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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?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Colorectal cancer
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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
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Anticipated start date
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10/05/1996
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Anticipated end date
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10/05/1999
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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First randomisation = 905, second randomisation = 354
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Interventions
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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
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Primary outcome measure(s)
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Survival
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Secondary outcome measure(s)
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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
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12583944
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Contact name
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Dr
Dionne
Cain
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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30/07/2009
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Date ISRCTN assigned
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06/04/2000
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