A Randomised Phase II/III Study of Taxol-BEP Versus BEP in Patients with Intermediate Prognosis Germ Cell Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000731-28-AT

Enrollment

200

Registered

2006-02-16

Start date

2006-03-23

Completion date

Unknown

Last updated

2013-03-25

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

Conditions

Patients with Intermediate Prognosis Germ cell Cancer MedDRA version: 8.1 Level: LLT Classification code 10061378

Interventions

Trade Name: Taxol Pharmaceutical Form: Solution for infusion Trade Name: Cisplatin Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cisplatin CAS Number: 0015663271 Concentration unit:

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Histologically proven germ cell cancer. Both seminoma and non seminoma are allowed. Fulfilling the criteria of the intermediate prognosis group according to the International Germ Cell Cancer Collaborative Group (IGCCCG) classification. Non Seminoma Testis/ retroperitonal primary and Intermediate markers and no non pulmonary metastases. Seminoma Any primary site Any LDH and any HCG Non-pulmonary visceral metastases present AFP within normal range Age > or = 16 years and 40ml/min. WBC > or = 3.0 X 10 9/l and platelets > or = 100 x 10 9/l No previous chemotherapy Before patient registration/randomisation, informed consent must be given according to ICH/EU GCP, and national/local regulations 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: Patients with all of the characteristics of the good prognosis group Patients with any of the characteristics of the poor prognosis group Previous chemotherapy Patients with a second malignancy except Basal cell skin cancer Age 50 years Female sex WHO- PS 3 or 4 Patients with a renal function impairment; creatinin clearance 1.25 X N and/or ASAT > 2 X N Patients with pre- existing neuropathy Patients with other serious illness or medical conditions incompatible with the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase II To determine the CR rates obtained with T-BEP and BEP in Patients with Intermediate Prognosis Germ Cell Cancer To further define the toxicity profile of T-BEP Phase III To compare disease-free survival between the 2 treatment arms. ;Secondary Objective: To compare the CR Rates and overall survival between the 2 treatment arms To document symptoms and aspects of quality of life at baseline and after treatment, and acute and intermediate (1-2 years) side effects of treatment;Primary end point(s): Phase III To compare disease- free survival between the 2 treatment arms	—

Measure

Time frame

Main Objective: Phase II To determine the CR rates obtained with T-BEP and BEP in Patients with Intermediate Prognosis Germ Cell Cancer To further define the toxicity profile of T-BEP Phase III To compare disease-free survival between the 2 treatment arms. ;Secondary Objective: To compare the CR Rates and overall survival between the 2 treatment arms To document symptoms and aspects of quality of life at baseline and after treatment, and acute and intermediate (1-2 years) side effects of treatment;Primary end point(s): Phase III To compare disease- free survival between the 2 treatment arms

—

Countries

Austria

Outcome results

None listed

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