Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hospices Civils de Lyon.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Hospices Civils de Lyon
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00198367
First received: September 13, 2005
Last updated: October 4, 2007
Last verified: October 2007
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Purpose
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Chemotherapy (Gemcitabine, Paclitaxel, 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: | Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study |
Resource links provided by NLM:
Drug Information available for:
Paclitaxel
Vinorelbine
Gemcitabine
Gemcitabine hydrochloride
Vinorelbine tartrate
U.S. FDA Resources
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities) [ Time Frame: at week 22 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | December 2007 |
These results justify the choice of the study design currently suggested, testing the preoperative feasibility
- chemotherapy: cisplatin-Gemzar (arm A) or
- chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C).
The results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III study.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Operable and resectable stage IIIA (T1-3, N2) NSCLC
- World Health Organization (WHO) performance status of 1 or less
Exclusion Criteria:
- Severe cardiac, respiratory, renal or hepatic failure
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198367
Locations
| France | |
| Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie | |
| Pierre-Benite, France | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Francoise Mornex, Pr | Hospices Civils de Lyon |
| Principal Investigator: | Bernard Milleron, Dr | IFCT |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00198367 History of Changes |
| Other Study ID Numbers: | IFCT-0101 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 4, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
operable and resectable stage IIIA (T1-3, N2) 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 Gemcitabine Vinorelbine Paclitaxel Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 19, 2013