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| Sponsors and Collaborators: |
University Hospital, Antwerp Universiteit Antwerpen Sanofi-Aventis |
|---|---|
| Information provided by: | University Hospital, Antwerp |
| ClinicalTrials.gov Identifier: | NCT00434668 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 99 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | December 2008 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paul R. Germonpre, MD PhD | paul.germonpre@ua.ac.be |
| Belgium, Antwerp | |
| University Hospital Antwerp | Recruiting |
| Edegem, Antwerp, Belgium, 2650 | |
| Principal Investigator: Paul R. Germonpre, MD PhD | |
| ZNA Middelheim | Recruiting |
| Antwerpen, Antwerp, Belgium, 2020 | |
| Contact: Daniella I Galdermans, MD danny.galdermans@telenet.be | |
| Principal Investigator: Daniella I Galdermans, MD | |
| St Augustinus ziekenhuis | Recruiting |
| Wilrijk, Antwerp, Belgium, 2610 | |
| Contact: Dirk Verresen, MD dirk.verresen@gvagroup.be | |
| Principal Investigator: Dirk Verresen, MD | |
| Principal Investigator: | Paul R. Germonpre, MD PhD | Thoracic Oncology Group Antwerp |
More Information
| Study ID Numbers: | TOGA 0501, Eudra CT 2005-004029-24 |
| Study First Received: | February 12, 2007 |
| Last Updated: | October 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00434668 History of Changes |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
|
Non-Small Cell Lung Cancer NSCLC Adjuvant chemotherapy for completely resected NSCLC |
|
Thoracic Neoplasms Adjuvants, Immunologic Carcinoma Docetaxel Vinorelbine Respiratory Tract Diseases Cisplatin |
Radiation-Sensitizing Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel Neoplasms Neoplasms by Site |
Vinorelbine Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
