This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a complete response patients received 3 cycles of treatment. If the PET - CT scan did not show a complete response patients received 4 cycles of treatment. After treatment, patients were followed up for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
Barts Health NHS Trust
London, United Kingdom
Hillingdon Hospitals NHS Foundation Trust
London, United Kingdom
2 - Year Progression Free Survival
Number of participants progression free 2 years after registration.
Time frame: 2 years
Metabolic Response Rate
Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.
Time frame: 21 days
Overall Survival
Survival status at 2 years after registration.
Time frame: 2 years
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