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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
cisplatin/docetaxel
cisplatin/vinorelbine
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, Adjuvant chemotherapy for completely resected NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ZNA Middelheim
  • University Hospital Antwerp
  • St Augustinus ziekenhuis

Outcomes

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

Full Information

First Posted
February 12, 2007
Last Updated
November 29, 2010
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00434668
Brief Title
Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer
Acronym
TOLEDO
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen, Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer, NSCLC, Adjuvant chemotherapy for completely resected NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin/docetaxel
Intervention Type
Drug
Intervention Name(s)
cisplatin/vinorelbine
Primary Outcome Measure Information:
Title
Success of delivery treatment; data collected during chemotherapy treatment
Title
Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle
Secondary Outcome Measure Information:
Title
Overall toxicity
Title
Progression free survival and overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul R. Germonpre, MD PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerpen
State/Province
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
St Augustinus ziekenhuis
City
Wilrijk
State/Province
Antwerp
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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