Study of chemotherapy for patients with good prognosis metastatic non-seminomatous testicular cancer

ISRCTN ISRCTN79658966
DOI https://doi.org/10.1186/ISRCTN79658966
Secondary identifying numbers TE03
Submission date
28/02/2001
Registration date
28/02/2001
Last edited
11/01/2019
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

Phone +44 20 7670 4600
Email pat.cook@ctu.mrc.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleStudy of chemotherapy for patients with good prognosis metastatic non-seminomatous testicular cancer
Study objectivesInvestigate whether the toxicity of chemotherapy in patients with small volume metastasis and low blood marker concentrations can be decreased by the reduction of the dose of Bleomycin given in the BEP regimen without loss of therapeutic activity.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer
InterventionArm 1: Bleomycin 30 mg x 3 per course, BEP x 4
Arm 2: Bleomycin 30 mg per course, BEP x 4
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Bleomycin, etoposide, cisplatin (platinum)
Primary outcome measureToxicity/response
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1986
Completion date31/12/1986

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants44
Key inclusion criteriaHistologically proven non-seminomatous testicular cancer
Key exclusion criteriaPrevious radiotherapy or chemotherapy
Date of first enrolment01/01/1986
Date of final enrolment31/12/1986

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 (MRC) (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

Editorial Notes

11/01/2019: No publications found. All search options exhausted.
29/03/2018: Verifying publication status with principal investigator.