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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Antwerp
• Collaborators: Sanofi; Universiteit Antwerpen
• Treatments: Cisplatin; Docetaxel; Vinorelbine

Criteria

Inclusion Criteria:

• completely resected pathological stage IB or II NSCLC

• adequate haematological, renal and liver function and condition

Exclusion Criteria:

• previous chemo or radiotherapy for NSCLC

• bronchoalveolar cell subtype

• second active primary malignancy or serious concomitant medical disease

• difficulties with adequate follow-up