ISRCTN ISRCTN27827390
DOI https://doi.org/10.1186/ISRCTN27827390
Protocol serial number TE12
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (UK)
Submission date
28/02/2001
Registration date
28/02/2001
Last edited
11/09/2007
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

Miss Sharon Naylor
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 title
Study objectivesCompare the efficacy of carboplatin with a combination of etoposide and cisplatin in the treatment of advanced metastatic seminoma.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer
InterventionArm 1 - 4 cycles of carboplatin.
Arm 2 - 4 cycles of cisplatin/etoposide.
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Carboplatin versus Etoposide / Cisplatin
Primary outcome measure(s)

Progression-free survival

Key secondary outcome measure(s)

Response, survival, toxicity.

Completion date31/12/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration112
Key inclusion criteriaHistologically verified testicular/extra-gonadal pure seminoma
Key exclusion criteriaPrevious chemotherapy.
Date of first enrolment01/08/1990
Date of final enrolment31/12/1995

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/12/2000 Yes No