NCT00434668

Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer

Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin/docetaxel
DRUG	cisplatin/vinorelbine

Timeline

• Start date: 2005-12-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2007-02-13
• Last updated: 2010-11-30

Locations

3 sites across 1 country: Belgium