ISRCTN ISRCTN75184582
DOI https://doi.org/10.1186/ISRCTN75184582
Protocol serial number RE03
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (MRC) (UK)
Submission date
28/02/2001
Registration date
28/02/2001
Last edited
26/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pat Cook
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleNephrectomy versus no nephrectomy for metastatic renal carcinoma
Study objectivesTo establish whether, in patients with metastatic renal carcinoma, nephrectomy has any advantage.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRenal Cancer
Intervention1. One group receives a nephrectomy
2. The other receives no nephrectomy
Intervention typeOther
Primary outcome measure(s)

1. Time to progression
2. Metastase rate
3. Quality of life
4. Survival time

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/12/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration120
Key inclusion criteria1. Patient should have locally operable disease and should be fit enough for nephrectomy
2. A renal tumour with clinical or radiological evidence of metastases
3. No previous malignancy (except non-melanotic skin cancer or in situ carcinoma of the cervix)
4. Written informed consent of the patient
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment01/12/1998

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

26/02/2016: No publications found, study status unverified.