A NOVEL HYBRID PROTOCOL FOR RELAPSED GERM CELL TUMOURSWITH POOR PROGNOSIS - GAMIO
- Conditions
- Relapsed Germ Cell Tumour with poor prognosis
- Registration Number
- EUCTR2008-005295-27-GB
- Lead Sponsor
- Barts and The London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 47
INCLUSION
1.Germ Cell Tumour (GCT)
2.Relapsed or progression on or following platinum-based chemotherapy (rising tumour markers or progressive disease on CT)
3.Neutrophil count > 1.0 x109/l
4.Platelets > 70 x109/l
5.Haemoglobin > 100g/l (may be transfused)
6.Calculated Creatinine clearance > 60mls/min or EDTA clearance of > 40ml/min
7.Age 16-65 years (Patient under 35 must have a raised LDH at relapse)
8.ECOG Performance status 0-3
9. FDG-PET CT scans prior to chemotherapy (within 14 days of study entry).
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range
EXCLUSION
1 Other malignancy except basal cell carcinoma
2Significant co-morbidity likely to make delivery of this treatment unsafe
3Currently enrolled in any other investigational drug study
4Unable or unwilling to give written informed consent
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