Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Multi-Centre Phase II Study Using Carboplatin AUC-10 for Metastatic Seminoma With IGCCCG Good Prognosis Disease-Therapy Directed by Initial Metabolic Response on PET-CT
Brief Summary:
Metastatic seminoma is a relatively uncommon disease. The most widely used treatment for this disease is chemotherapy with the drugs, cisplatin and etoposide with or without the addition of bleomycin. This treatment combination has shown good survival rates however it is toxic usually requires an inpatient visit with administration over three days and can cause significant nausea, malaise, alopecia, risk of kidney damage, hypertension and high tone hearing loss.
Previous studies have demonstrated that carboplatin is also effective in treating this disease type. Progression free survival is less than that seen with the combination chemotherapy yet overall survival is the same between the two treatments because of the effectiveness of second line salvage chemotherapy. Single agent carboplatin is a less toxic treatment and more convenient as it is given as a day case.
A recent study run by the Orchid Clinical Trials Group looked at whether carboplatin (AUC10) is not only associated with fewer side effects, but more convenient to give as an outpatient treatment and that it is comparable in terms of cure rate. 20 patients were recruited to the trial and the results were encouraging with only one relapsed patient. This patient went on to be cured by conventional treatment. The positive outcome of the AUC10 trial has led to the design of this new multi centre study.
This open labeled, multi centre trial will recruit up to 50 patients with good prognosis metastatic seminoma. All patients will receive three cycles of carboplatin AUC 10. Patients will be followed up for survival and closely monitored for side effects during treatment. Patients will have a PET-CT scan before they start treatment and after the completion of their first cycle. We hope that this scan will help us to iden