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

• Conditions: Patients with Intermediate Prognosis Germ cell Cancer; MedDRA version: 8.1Level: LLTClassification code 10061378

• Registration Number: EUCTR2004-000731-28-AT
• Lead Sponsor: EORTC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-16
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 200

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 < or= 50 years, male sex
WHO performance Status 0, 1 or 2
Creatinine clearance > 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

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 < 16 years, or > 50 years
Female sex
WHO- PS 3 or 4
Patients with a renal function impairment; creatinin clearance < 40ml/min, unless this is due to obstructive uropathy that can be relieved by nephrostomy
Patients with liver function impairment; bilirubin > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase II<br><br>To determine the CR rates obtained with T-BEP and BEP in Patients with Intermediate Prognosis Germ Cell Cancer<br><br>To further define the toxicity profile of T-BEP<br><br>Phase III<br><br>To compare disease-free survival between the 2 treatment arms.<br>;Secondary Objective: To compare the CR Rates and overall survival between the 2 treatment arms<br><br>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<br><br>To compare disease- free survival between the 2 treatment arms