Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
20/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr PM Wilkinson

ORCID ID

Contact details

Clinical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 0161 446 3261
Peter.Wilkinson@christie-tr.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0063044257

Study information

Scientific title

Treatment of high risk testicular tumour with high dose chemotherapy with peripheral blood stem cells

Acronym

Study hypothesis

To assess the efficacy of high dose chemotherapy with peripheral blood stem cells to see if the response rate is improved compared to conventional therapy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer: Testicular

Intervention

High dose chemotherapy with peripheral blood stem cells vs no high dose

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Time to white cell and platelet recovery
2. Confirmation of response
3. Assessment of toxicity by standard World Health Organisation (WHO) grades

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1994

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with histological proven non-seminomatous germ cell tumours
2. High risk factors as defined by MRC prognostic group

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

6

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/1994

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Oncology
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Christie Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/04/2016: No publications found, verifying study status with principal investigator.