Multizentrische randomisierte Phase II Studie zur Therapie des lokal fortgeschrittenen oder metastasierten NSCLC (Stadium IIIB/IV) mit Cisplatin/Docetaxel oder Oxaliplatin/DocetaxelA multicenter randomized phase II trial for the therapy of locally advanced or metastatic NSCLC (stage IIIB/IV) with cisplatin/docetaxel or oxaliplatin/docetaxel

Active, not recruiting

• Conditions: locally advanced or metastatic NSCLC (stadium IIIB/ IV)

• Registration Number: EUCTR2008-002197-35-DE
• Lead Sponsor: Krankenhaus Nordwest GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-13
• Last Update Posted: 25 February 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

histologically or cytologically confirmed NSCLC, stadium IIIB (curative treatment impossible) or IV.
no prior cytostatic chemotherapy in metastatic state
female and male patients aged >18 years
ECOG = 2
Leukozytes > 3.000/µl
Thrombozytes > 100.000/µl
creatinine serum level = 1.25x ULN or Creatinine-Clearance > 45 ml/min
parallel radiotherapy possible if target lesion not in radiation field
written informed consent
life expectancy > 3 months

Are the trial subjects under 18? no
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hypersensitivity for Cisplatin, Oxaliplatin or Docetaxel
Neoadjuvant or adjuvant chemotherapy in the last 6 months
radiotherapy in the last 28 days
relevant systemic concomitant diseases
Cardiomyopathy or heart insufficiency stadium II-IV according to NYHA
second malignancy < 5 years ago
brain metastases
severe internal dysfunction or acute infection
peripheral polyneuropathy > NCI grade II
severe impairment of liver function (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)participation in another clinical trial
pregnancy or lactation

Study & Design

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