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 [CAR-PET] - CAR-PET
- Conditions
- Metastatic seminoma
- Registration Number
- EUCTR2009-009882-33-GB
- Lead Sponsor
- St Bartholomew's and The London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion criteria
1.Metastatic seminoma-IGCCCG good prognosis.
2.Glomerular filtration rate by EDTA clearance over 25 ml/min (a measured creatinine clearance using Cockcroft and Gault would be allowed if unable to perform EDTA clearance in adequate timeframe)
3.ECOG Performance status 0-3
4.Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable)
5.Males aged =18 and =75 years
6.Able to give written informed consent prior to study entry
7.Patients must be sterile or agree to use adequate contraception during the period of therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria:
1.Metastatic seminoma with any non-pulmonary visceral metastases
2.Raised Alpha-fetoprotein
3.Any previous chemotherapy or radiotherapy
4.Currently enrolled in any other investigational drug study
5.Other malignancy except basal cell
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method