Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
14/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctu.mrc.ac.uk/studies/TE08.asp

Contact information

Type

Scientific

Primary contact

Miss Sharon Naylor

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00003420

Protocol/serial number

TE08

Study information

Scientific title

Acronym

Study hypothesis

To assess the value of frequent abdominal and chest CT scans in the follow-up of patients with stage I non-seminomatous germ cell tumours (NSGCT) who are on a surveillance programme. After baseline scans confirming stage I disease, patients will be randomised between two and five further CT scans during their follow up, with the nature and frequency of all other investigations remaining constant.

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

Condition

Cancer

Intervention

1. One group receives two CT scans
2. The other group receives five CT scans

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Stage of the disease at relapse (IGCC Classification), time from entry to detection of relapse.

Secondary outcome measures

Overall survival, identification of the first investigation or sign prompting diagnosis of relapse, incidence of second malignancies and balance of costs of treatment determined through health economics study

Overall trial start date

01/12/1997

Overall trial end date

30/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed stage I non-seminomatous germ cell tumour of the testis
2. Patients must be able to attend for regular surveillance
3. The interval between orchidectomy and randomisation should not exceed 8 weeks
4. No co-existent or previously treated malignant disease, except successfully treated non-melanotic skin cancer

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

900

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/1997

Recruitment end date

30/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17416851

Publication citations

  1. Results

    Rustin GJ, Mead GM, Stenning SP, Vasey PA, Aass N, Huddart RA, Sokal MP, Joffe JK, Harland SJ, Kirk SJ, , Randomized trial of two or five computed tomography scans in the surveillance of patients with stage I nonseminomatous germ cell tumors of the testis: Medical Research Council Trial TE08, ISRCTN56475197--the National Cancer Research Institute Testis Cancer Clinical Studies Group., J. Clin. Oncol., 2007, 25, 11, 1310-1315, doi: 10.1200/JCO.2006.08.4889.

Additional files

Editorial Notes