Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
07/07/2014
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

Prof T Oliver

ORCID ID

Contact details

Medical Oncology Department
St Bartholomews Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00003014

Protocol/serial number

TE19

Study information

Scientific title

Acronym

Study hypothesis

1. To determine whether relapse rates are equivalent in patients with Stage 1 seminoma testis treated with either adjuvant radiotherapy or with single agent carboplatin at a dose of AUC 7 [7 x (GFR + 25)]
2. To document symptoms and aspects of quality of life before and after treatment, and to compare the acute and intermediate (1-2 year) side-effects of treatment using a diary card and EORTC QLQ-C30 together with a developmental testicular tumour questionnaire
3. To collect data on the incidence of late side-effects of treatment (such as bowel dysfunction) and second malignancies (the latter in parallel with an ongoing retrospective study of 2nd malignancies in such patients)

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

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Testicular cancer

Intervention

1. One group receives radiotherapy following orchidectomy
2. The other group receives single agent carboplatin

Intervention type

Drug

Phase

Not Specified

Drug names

Carboplatin

Primary outcome measures

Time to relapse. Survival is expected to approach 100%

Secondary outcome measures

Quality of life, side effects (acute and late)

Overall trial start date

13/06/1996

Overall trial end date

13/06/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed seminomatous germ cell tumour of the testis which is classified either as ‘classical’ or ‘anaplastic’ (NB patients with combined teratoma/seminoma and spermatocytic seminoma are excluded)
2. Stage 1 disease:
2.1. No evidence of metastatic disease on clinical examination
2.2. Normal chest X-ray
2.3. Normal chest, abdominal and pelvic CT scan
2.4. Normal serum tumour markers (AFP, HCG). Raised HCG pre-orchidectomy does not render a patient ineligible, but a raised AFP does
3. Patients with primary tumour pathologically staged pT1/ pT2/ pT3 are eligible except those with involvement of the cut end of the spermatic cord
4. Patients with previous inguino-pelvic or scrotal surgery have to be treated with dog leg field if randomised to radiotherapy
5. The interval between orchidectomy and randomisation should not exceed 8 weeks
6. No co-existant or previously treated malignant disease, except treated non-melanotic skin cancer
7. No medical condition or other factor preventing adherence to the study schedule and follow-up
8. Consent to be randomised into the proposed study
9. Glomerular filtration rate >40 ml/min

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

1447

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

13/06/1996

Recruitment end date

13/06/2000

Locations

Countries of recruitment

Australia, Austria, Belgium, Bosnia and Herzegovina, Denmark, France, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Russian Federation, United Kingdom

Trial participating centre

Medical Oncology Department
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 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 (MRC) (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

2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/16039331
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21282539

Publication citations

  1. Results

    Oliver RT, Mason MD, Mead GM, von der Maase H, Rustin GJ, Joffe JK, de Wit R, Aass N, Graham JD, Coleman R, Kirk SJ, Stenning SP, , Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial., Lancet, 366, 9482, 293-300, doi: 10.1016/S0140-6736(05)66984-X.

  2. Results

    Oliver RT, Mead GM, Rustin GJ, Joffe JK, Aass N, Coleman R, Gabe R, Pollock P, Stenning SP, Randomized trial of carboplatin versus radiotherapy for stage I seminoma: mature results on relapse and contralateral testis cancer rates in MRC TE19/EORTC 30982 study (ISRCTN27163214)., J. Clin. Oncol., 2011, 29, 8, 957-962, doi: 10.1200/JCO.2009.26.4655.

Additional files

Editorial Notes