NCT02272816

Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Seminoma

Interventions

Type	Name	Description
DRUG	Carboplatin AUC-10	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.

Timeline

• Start date: 2012-02-13
• Primary completion: 2017-10-13
• Completion: 2017-10-13
• First posted: 2014-10-23
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

2 sites across 1 country: United Kingdom