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ISRCTN
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ISRCTN89397749
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DOI
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10.1186/ISRCTN89397749
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised trial of alpha-interferon versus medroxyprogesterone acetate for metastatic renal carcinoma
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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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REO1
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Study hypothesis
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To establish whether, in patients with metastatic renal carcinoma, recombinant alpha-interferon has any advantage over medroxyprogesterone acetate.
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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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Cancer
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Participants - inclusion criteria
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1. Histologically or cytologically proven renal cell carcinoma with evaluable metastatic disease
2. World Health Organisation (WHO) performance status 0-2
3. No previous malignancy (except non-melanotic skin cancer or in situ carcinoma of the cervix)
4. Three groups of patients are eligible:
(a) Those patients who have had a nephrectomy in the past and develop metastatic disease during follow up. Patients can be randomised when metastatic disease has been confirmed and the patient fits the other eligibility criteria.
(b) Those patients who present with metastatic disease and have had the primary tumour removed within the last 4 weeks. Patients should be randomised once the nephrectomy has been performed and the wound has healed.
(c) Those patients who present with metastatic disease where nephrectomy is not planned.
Patients can be randomised at presentation.
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Participants - exclusion criteria
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Patients with cardiac disease which may preclude alpha-interferon or those with known brain metastases must be excluded. No previous RT, hormonal, cytotoxic or immuno-therapy within 12 weeks of the proposed date of randomisation.
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Anticipated start date
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01/01/1992
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Anticipated end date
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01/12/1998
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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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600
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Interventions
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1. One group receives recombinant alpha-interferon
2. The other group receives medroxyprogesterone
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Primary outcome measure(s)
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1. Survival time
2. Response rate
3. Time to progression
4. Quality of life
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Secondary outcome measure(s)
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Not provided at time of registration
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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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1. 1994 design described in http://www.ncbi.nlm.nih.gov/pubmed/7846423
2. 1999 early results in http://www.ncbi.nlm.nih.gov/pubmed/10023944
3. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14970855
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Contact name
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Mrs
Pat
Cook
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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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pat.cook@ctu.mrc.ac.uk
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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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28/02/2001
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Last edited
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04/09/2009
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Date ISRCTN assigned
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28/02/2001
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