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Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT00198367
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Cisplatin-Gemzar Drug: Cisplatin-Navelbine-Radiotherapy Drug: Carboplatin-Taxol-Radiotherapy Phase 2

Detailed Description:

These results justify the choice of the study design currently suggested, testing the preoperative feasibility

  1. chemotherapy: cisplatin-Gemzar (arm A) or
  2. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2003
Primary Completion Date : January 2008
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cisplatin-Gemzar
Drug: Cisplatin-Gemzar
Experimental: Cisplatin-Navelbine-Radiotherapy
Drug: Cisplatin-Navelbine-Radiotherapy
Experimental: Carboplatin-Taxol-Radiotherapy
Drug: Carboplatin-Taxol-Radiotherapy

Primary Outcome Measures :
  1. percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities) [ Time Frame: at week 22 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198367

Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie
Pierre-Benite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Francoise Mornex, Pr Hospices Civils de Lyon
Principal Investigator: Bernard Milleron, Dr IFCT

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00198367     History of Changes
Other Study ID Numbers: IFCT-0101
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Hospices Civils de Lyon:
operable and resectable stage IIIA (T1-3, N2) NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs