TE23: Randomised Phase II trial of intensive induction chemotherapy (CBOP/BEP) and standard BEP chemotherapy in poor prognosis male germ cell tumours. - MRC TE23 Study
- Conditions
- Poor prognosis male germ cell tumoursMedDRA version: 9.1 Level: LLT Classification code 10043333 Term: Testicular germ cell tumour mixed stage IIIMedDRA version: 9.1 Level: LLT Classification code 10015802 Term: Extragonadal primary germ cell tumour mixed stage III
- Registration Number
- EUCTR2004-000405-22-GB
- Lead Sponsor
- Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 88
1. Germ cell tumour of any extracranial primary site. Diagnosis of GCT will be accepted on the basis of histological diagnosis or the presence of raised AFP (>1000ng/ml) or HCG (>5000iu/l) with appropriate clinical picture in a man aged <45 years
2. Poor prognosis features as defined by IGCCCG criteria. One or more of
? AFP >10 000 ng/ml
? HCG >50 000 iu/l
? LDH >10x normal limit of laboratory
? Non pulmonary visceral metastases
? Mediastinal primary site
3. Performance status 0-3
4. GFR >50mls/min. Patients with initial GFR less than 50mls/min can be entered if this is due to obstructive nephropathy and can be relieved by stenting or nephrostomy
5. No co morbid condition which will prevent protocol treatment
6. No previous chemotherapy
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
All patients fulfilling inclusion criteria above will be eligible for this trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the outcome of poor prognosis germ cell tumour patients treated with two different chemotherapy regimens in an open randomised phase II trial. This will be assessed by analysis of the proportion of patients achieving a complete response of a partial response.;Secondary Objective: Overall survival, progression-free survival and toxicity.;Primary end point(s): The primary outcome measure will be response rates: proportion achieving complete response (disappearance of all disease and normal tumour markers) or partial response (residual masses unresected) with negative markers (PR/MK-ve).
- Secondary Outcome Measures
Name Time Method