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

This study has been completed.
Sponsor:
Collaborators:
Universiteit Antwerpen
Sanofi
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00434668
First received: February 12, 2007
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: cisplatin/docetaxel
Drug: cisplatin/vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Overall toxicity
  • Progression free survival and overall survival

Estimated Enrollment: 99
Study Start Date: December 2005
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434668

Locations
Belgium
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
Sanofi
Investigators
Principal Investigator: Paul R. Germonpre, MD PhD Thoracic Oncology Group Antwerp
  More Information

No publications provided

Responsible Party: Prof Dr P Germonpré, Thoracale Oncologie Groep Antwerpen
ClinicalTrials.gov Identifier: NCT00434668     History of Changes
Other Study ID Numbers: TOGA 0501, Eudra CT 2005-004029-24
Study First Received: February 12, 2007
Last Updated: November 29, 2010
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Docetaxel
Cisplatin
Vinblastine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014