|
ISRCTN
|
ISRCTN27163214
|
|
DOI
|
10.1186/ISRCTN27163214
|
|
ClinicalTrials.gov identifier
|
NCT00003014
|
|
EudraCT number
|
|
|
Public title
|
A randomised comparison of single agent carboplatin with radiotherapy for stage I seminoma of the testis following orchidectomy
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
TE19
|
|
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).
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
International
|
|
Disease/condition/study domain
|
Testicular Cancer
|
|
Participants - 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:
- No evidence of metastatic disease on clinical examination
- Normal chest X-ray
- Normal chest, abdominal and pelvic CT scan
- 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
|
|
Participants - exclusion criteria
|
Does not meet inclusion criteria
|
|
Anticipated start date
|
13/06/1996
|
|
Anticipated end date
|
13/06/2000
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
1447
|
|
Interventions
|
1. One group receives radiotherapy following orchidectomy
2. The other group receives single agent carboplatin
|
|
Primary outcome measure(s)
|
Time to relapse. Survival is expected to approach 100%
|
|
Secondary outcome measure(s)
|
Quality of life, side effects (acute and late)
|
|
Sources of funding
|
Medical Research Council (MRC) (UK)
|
|
Trial website
|
|
|
Publications
|
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16039331
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21282539
|
|
Contact name
|
Prof
T
Oliver
|
|
Address
|
Medical Oncology Department
St Bartholomews Hospital
West Smithfield
|
|
City/town
|
London
|
|
Zip/Postcode
|
EC1A 7BE
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
06/04/2000
|
|
Last edited
|
19/05/2011
|
|
Date ISRCTN assigned
|
06/04/2000
|
