Stage I seminoma testis Cancer Testicular cancer
Conditions
Interventions
1. One group receives 30 Gy, given in 15 daily (Monday through Friday) fractions of 2 Gy
2. The other group receives 20 Gy in 10 daily fractions of 2 Gy
Follow-up assessments will take place every th
chest x-rays are required at the six, 12-, 20-, 30-, and 36-month visits
and Computed Tomography (CT) scans of chest, abdomen, and pelvis are required at the 12-, 24-, and 36-month visits.
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed seminomatous germ cell tumour of the testis that is categorised as either 'Classical' or 'Anaplastic' 2. Stage I disease, based on clinical and radiologic examination, and normal postorchidectomy Alpha-FetoProtein (AFP) and Human Chorionic Gonadotropin (HCG) 3. All 'T' categories of primary tumour 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' fields 5. The interval between orchidectomy and randomisation should not exceed eight weeks. Treatment should start within two weeks thereafter 6. Consent to be randomised into the proposed study
Exclusion criteria
Exclusion criteria: 1. Increased serum alphafetoprotein (AFP) (but not human chorionic gonadotropin [HCG]) preorchidectomy 2. Coexistent or previously treated malignant disease or other condition or factor preventing adherence to the study schedule and follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free rate, with relapse defined as the development of new masses (detected clinically or radiologically), or increasing tumor-specific markers (AFP, HCG). | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact of dose on acute morbidity and quality of life. | — |
Countries
United Kingdom
Outcome results
None listed