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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00434668
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : November 30, 2010
Universiteit Antwerpen
Information provided by:
University Hospital, Antwerp

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: cisplatin/docetaxel Drug: cisplatin/vinorelbine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2005
Primary Completion Date : September 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  1. Overall toxicity
  2. Progression free survival and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00434668

ZNA Middelheim
Antwerpen, Antwerp, Belgium, 2020
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
St Augustinus ziekenhuis
Wilrijk, Antwerp, Belgium, 2610
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Principal Investigator: Paul R. Germonpre, MD PhD Universiteit Antwerpen

Responsible Party: Prof Dr P Germonpré, Thoracale Oncologie Groep Antwerpen Identifier: NCT00434668     History of Changes
Other Study ID Numbers: TOGA 0501
Eudra CT 2005-004029-24
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010

Keywords provided by University Hospital, Antwerp:
Non-Small Cell Lung Cancer
Adjuvant chemotherapy for completely resected NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic