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

Antwerp University Hospital (UZA)

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: cisplatin/docetaxel; Drug: cisplatin/vinorelbine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00434668

Eudra CT 2005-004029-24

TOGA 0501

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)