Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT00434668
- Lead Sponsor
- University Hospital, Antwerp
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle Success of delivery treatment; data collected during chemotherapy treatment
- Secondary Outcome Measures
Name Time Method Overall toxicity Progression free survival and overall survival
Trial Locations
- Locations (3)
University Hospital Antwerp
🇧🇪Edegem, Antwerp, Belgium
ZNA Middelheim
🇧🇪Antwerpen, Antwerp, Belgium
St Augustinus ziekenhuis
🇧🇪Wilrijk, Antwerp, Belgium