A randomised trial of alpha-interferon versus medroxyprogesterone acetate for metastatic renal carcinoma

ISRCTN	ISRCTN89397749
DOI	https://doi.org/10.1186/ISRCTN89397749
Secondary identifying numbers	REO1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Pat Cook
Scientific

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

Email	pat.cook@ctu.mrc.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	To establish whether, in patients with metastatic renal carcinoma, recombinant alpha-interferon has any advantage over medroxyprogesterone acetate.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer
Intervention	1. One group receives recombinant alpha-interferon 2. The other group receives medroxyprogesterone
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/01/1992
Completion date	01/12/1998

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	600
Key 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.
Key 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.
Date of first enrolment	01/01/1992
Date of final enrolment	01/12/1998

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Other publications	design described	15/11/1994	Yes	No
Results article	early results	02/01/1999	Yes	No
Results article	results	23/02/2004	Yes	No