A randomised comparison of single agent carboplatin with radiotherapy for stage I seminoma of the testis following orchidectomy

ISRCTN	ISRCTN27163214
DOI	https://doi.org/10.1186/ISRCTN27163214
ClinicalTrials.gov number	NCT00003014
Secondary identifying numbers	TE19

Submission date: 06/04/2000
Registration date: 06/04/2000
Last edited: 07/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof T Oliver
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
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(s)	Not provided at time of registration
Condition	Testicular cancer
Intervention	1. One group receives radiotherapy following orchidectomy 2. The other group receives single agent carboplatin
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Carboplatin
Primary outcome measure	Time to relapse. Survival is expected to approach 100%
Secondary outcome measures	Quality of life, side effects (acute and late)
Overall study start date	13/06/1996
Overall study end date	13/06/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target number of participants	1447
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 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
England
France
Israel
Italy
Netherlands
New Zealand
Norway
Poland
Russian Federation
United Kingdom

Study participating centre

Medical Oncology Department

London
EC1A 7BE
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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2005		Yes	No
Results article	results	10/03/2011		Yes	No