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Completed

NCT Number: NCT00434668

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ZNA Middelheim, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cisplatin/docetaxel

Drug

cisplatin/vinorelbine

Drug

Primary outcomes

  1. Success of delivery treatment; data collected during chemotherapy treatment

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

Secondary outcomes

  1. Overall toxicity

  2. Progression free survival and overall survival

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Sanofi
  • Universiteit Antwerpen

Registry information

Official study 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

Acronym: TOLEDO

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Feb 13, 2007
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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