Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma (NCT02272816) | Clinical Trial Compass
CompletedPhase 2
Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma
United Kingdom48 participantsStarted 2012-02-13
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexMALE
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Inclusion criteria
✓. Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis.
✓. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min.
✓. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3.
✓. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable).
✓. Males aged ≥18 and ≤75 years.
✓. Able to give written informed consent prior to study entry.
✓. Patients must be sterile or agree to use adequate contraception during the period of therapy.
Exclusion criteria
✕. Metastatic seminoma with any non-pulmonary visceral metastases.