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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434668

Acronym

TOLEDO

Enrollment

Registered

2007-02-13

Start date

2005-12-31

Completion date

2010-11-30

Last updated

2010-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer, NSCLC, Adjuvant chemotherapy for completely resected NSCLC

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.

Interventions

DRUGcisplatin/docetaxel

DRUGcisplatin/vinorelbine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Overall toxicity	—
Progression free survival and overall survival	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026