Non-small Cell Lung Cancer Clinical Trial
— TOLEDOOfficial title:
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
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | November 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | ZNA Middelheim | Antwerpen | Antwerp |
Belgium | University Hospital Antwerp | Edegem | Antwerp |
Belgium | St Augustinus ziekenhuis | Wilrijk | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Sanofi, Universiteit Antwerpen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success of delivery treatment; data collected during chemotherapy treatment | |||
Primary | Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle | |||
Secondary | Overall toxicity | |||
Secondary | Progression free survival and overall survival |
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