Contact information
Type
Scientific
Primary contact
Mrs Pat Cook
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
pat.cook@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REO1
Study information
Scientific title
Acronym
Study hypothesis
To establish whether, in patients with metastatic renal carcinoma, recombinant alpha-interferon has any advantage over medroxyprogesterone acetate.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cancer
Intervention
1. One group receives recombinant alpha-interferon
2. The other group receives medroxyprogesterone
Intervention type
Drug
Phase
Not Specified
Drug names
alpha-interferon versus medroxyprogesterone acetate
Primary outcome measure
1. Survival time
2. Response rate
3. Time to progression
4. Quality of life
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1992
Overall trial end date
01/12/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
600
Participant exclusion criteria
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.
Recruitment start date
01/01/1992
Recruitment end date
01/12/1998
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
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
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
Publication citations
-
Design described
Fayers PM, Cook PA, Machin D, Donaldson N, Whitehead J, Ritchie A, Oliver RT, Yuen P, On the development of the Medical Research Council trial of alpha-interferon in metastatic renal carcinoma. Urological Working Party Renal Carcinoma Subgroup., Stat Med, 1994, 13, 21, 2249-2260.
-
Early results
Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Medical Research Council Renal Cancer Collaborators., Lancet, 1999, 353, 9146, 14-17.
-
Results
Royston P, Sauerbrei W, Ritchie A, Is treatment with interferon-alpha effective in all patients with metastatic renal carcinoma? A new approach to the investigation of interactions., Br. J. Cancer, 2004, 90, 4, 794-799, doi: 10.1038/sj.bjc.6601622.