Metastatic seminoma
Conditions
Interventions
Product Name: Carboplatin 10mg/ml Intravenous infusion
Pharmaceutical Form: Solution for infusion
Sponsors
St Bartholomew's and The London NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Metastatic seminoma-IGCCCG good prognosis. 2. Glomerular filtration rate by EDTA clearance over 25 ml/min (a measured creatinine clearance using Cockcroft and Gault would be allowed if unable to perform EDTA clearance in adequate timeframe) 3. ECOG Performance status 0-3 4. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable) 5. Males aged =18 and =75 years 6. Able to give written informed consent prior to study entry 7. Patients must be sterile or agree to use adequate contraception during the period of therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Metastatic seminoma with any non-pulmonary visceral metastases 2. Raised Alpha-fetoprotein 3. Any previous chemotherapy or radiotherapy 4. Currently enrolled in any other investigational drug study 5. Other malignancy except basal cell
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, efficacy and toxicity of carboplatin AUC-10 in metastatic seminoma in a multi centre setting. ; Secondary Objective: To see if, by using FDG PET-CT to assess metabolic response, the number of patients requiring 4 cycles can be reduced. ; Primary end point(s): Progression free survival rate at 2 years post treatment. | — |
Countries
United Kingdom
Outcome results
None listed