ISRCTN ISRCTN14535482
DOI https://doi.org/10.1186/ISRCTN14535482
Secondary identifying numbers TE13
Submission date
28/02/2001
Registration date
28/02/2001
Last edited
29/10/2019
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

Miss Sharon Naylor
Scientific

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

Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleTreatment of poor prognosis metastatic teratoma
Study objectivesDetermine whether treatment with the intensive regimen BOP/VIP-B is more effective than BEP/P.
To determine the effect of G-CSF on the proportion of patients receiving full dose intensity of combination chemotherapy with either regimen.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMetastatic teratoma
InterventionArm 1 - Without granulocyte colony stimulating factor (G-CSF), BEP/EP.
Arm 2 - Without G-CSF, BOP/VIP-B.
Arm 3 - With G-CSF, BEP/EP.
Arm 4 - With G-CSF, BOP/VIP-B.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Several
Primary outcome measureProgression-free survival
Secondary outcome measuresResponse rate, overall survival
Overall study start date01/02/1991
Completion date31/12/1994

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants154
Key inclusion criteriaHistologically proven non-seminomatous germ cell tumour
Key exclusion criteriaPrevious radiotherapy or chemotherapy
Date of first enrolment01/02/1991
Date of final enrolment31/12/1994

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

29/10/2019: No publications found. All search options exhausted.