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

Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434668
• Other study ID #: TOGA 0501
• Secondary ID: Eudra CT 2005-00
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2007
• Last updated: November 29, 2010
• Start date: December 2005
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• cisplatin/docetaxel

• cisplatin/vinorelbine

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen	Antwerp
Belgium	University Hospital Antwerp	Edegem	Antwerp
Belgium	St Augustinus ziekenhuis	Wilrijk	Antwerp

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Sanofi, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of delivery treatment; data collected during chemotherapy treatment
Primary	Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle
Secondary	Overall toxicity
Secondary	Progression free survival and overall survival