Status:
COMPLETED
Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
University College London Hospitals
Conditions:
Metastatic Seminoma
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief 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-co...
Eligibility Criteria
Inclusion
- 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
- Metastatic seminoma with any non-pulmonary visceral metastases.
- Raised Alpha-fetoprotein.
- Any previous chemotherapy or radiotherapy.
- Currently enrolled in any other investigational drug study.
- Other malignancy except basal cell.
Key Trial Info
Start Date :
February 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02272816
Start Date
February 13 2012
End Date
October 13 2017
Last Update
January 25 2019
Active Locations (2)
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1
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
2
Hillingdon Hospitals NHS Foundation Trust
London, United Kingdom, HA6 2RN