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

University Hospital, Antwerp99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

cisplatin/docetaxelDRUG

cisplatin/vinorelbineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

ZNA Middelheim

Antwerp, Antwerp, Belgium

University Hospital Antwerp

Edegem, Antwerp, Belgium

St Augustinus ziekenhuis

Wilrijk, Antwerp, Belgium

Outcomes

Primary Outcomes

Success of delivery treatment; data collected during chemotherapy treatment

Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle

Secondary Outcomes

Overall toxicity

Progression free survival and overall survival

Data from ClinicalTrials.gov

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