Study of carboplatin based combination chemotherapy for good prognosis metastatic malignant teratoma

ISRCTN ISRCTN69711558
DOI https://doi.org/10.1186/ISRCTN69711558
Secondary identifying numbers TE09
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

Mrs Pat Cook
Scientific

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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo define equivalent activity and lower toxicity of combination chemotherapy containing carboplatin rather than cisplatin
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer
InterventionArm 1 - 4 cycles BEP.
Arm 2 - 4 cycles CEB.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Carboplatin
Primary outcome measureComplete remission on chemotherapy or chemotherapy + surgery. Progression-free survival. Survival, toxicity.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/1989
Completion date31/12/1993

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants450
Key inclusion criteriaHistologically confirmed non-seminomatous germ cell tumour of testis or combined seminoma/teratoma or seminoma with unequivocal raised serum alpha feto protein concentration
Key exclusion criteriaPrevious chemotherapy.
Date of first enrolment01/06/1989
Date of final enrolment31/12/1993

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

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

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/05/1997 Yes No