Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
04/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes