A randomised trial of alpha-interferon versus medroxyprogesterone acetate for metastatic renal carcinoma
| ISRCTN | ISRCTN89397749 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89397749 |
| Protocol serial number | REO1 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 04/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Pat Cook
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| pat.cook@ctu.mrc.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | alpha-interferon versus medroxyprogesterone acetate |
| Primary outcome measure(s) |
1. Survival time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | early results | 02/01/1999 | Yes | No | |
| Results article | results | 23/02/2004 | Yes | No | |
| Other publications | design described | 15/11/1994 | Yes | No |
