GAMEC-SHORT (S) & GAMEC-ANTHRACYCLINE (A) RISK-ADAPTED PROTOCOL FOR RELAPSED GERM CELL TUMOURS (GCT) - GAMEC II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001963-52-GB

Enrollment

Registered

2006-05-18

Start date

2006-07-03

Completion date

Unknown

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-labelled, non-randomised clinical trial in patients with relapsed germ cell tumours (GCT.)

Interventions

Trade Name: NEULASTA Product Name: pegfilgrastim Pharmaceutical Form: Solution for injection INN or Proposed INN: Pegfilgrastim CAS Number: 208265-92-3 Current Sponsor code: L03AA13 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 X 109/l 4.Platelets > 70 X 109/l 5.Haemoglobin > 100g/l (may be transfused) 6.Creatinine or EDTA clearance > 60mls/min 7.Age 16-65 years 8.ECOG Performance status 0-3 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 criteria

Exclusion criteria: 1.Other malignancy except basal cell carcinoma 2.Evidence of clinically significant cardiac failure, unstable angina or uncontrolled hypertension 3.Currently enrolled in any other investigational drug study 4.Unable or unwilling to give written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To establish the response rates to GAMEC-S or GAMEC-A 2. To establish the safety and efficacy of substitution of epirubicin for etoposide (GAMEC-A regimen) 3.To establish the toxicity of GAMEC-A 4.To establish progression free survival (PFS) 5.To establish whether shortening GAMEC-S in patients without adverse prognostic factors reduces toxicity without compromising survival. ;Secondary Objective: Relapse free survival Overall survival Toxicity ;Primary end point(s): Progression free survival	—

Measure

Time frame

Main Objective: 1.To establish the response rates to GAMEC-S or GAMEC-A 2. To establish the safety and efficacy of substitution of epirubicin for etoposide (GAMEC-A regimen) 3.To establish the toxicity of GAMEC-A 4.To establish progression free survival (PFS) 5.To establish whether shortening GAMEC-S in patients without adverse prognostic factors reduces toxicity without compromising survival. ;Secondary Objective: Relapse free survival Overall survival Toxicity ;Primary end point(s): Progression free survival

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026