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

Completed

• Conditions: Testicular cancer; Cancer

• Registration Number: ISRCTN27163214
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 1447

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

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified