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 (NCT)	NCT00003014
Protocol serial number	TE19
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof T Oliver
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Carboplatin
Primary outcome measure(s)	Time to relapse. Survival is expected to approach 100%
Key secondary outcome measure(s)	Quality of life, side effects (acute and late)
Completion date	13/06/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	1447
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	13/06/1996
Date of final enrolment	13/06/2000

Medical Oncology Department

London
EC1A 7BE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes