We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00198367
First Posted: September 20, 2005
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  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: Cisplatin-Gemzar Drug: Cisplatin-Navelbine-Radiotherapy Drug: Carboplatin-Taxol-Radiotherapy Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

Enrollment: 120
Study Start Date: January 2003
Study Completion Date: July 2012
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin-Gemzar
Cisplatin-Gemzar
Drug: Cisplatin-Gemzar
Experimental: Cisplatin-Navelbine-Radiotherapy
Cisplatin-Navelbine-Radiotherapy
Drug: Cisplatin-Navelbine-Radiotherapy
Experimental: Carboplatin-Taxol-Radiotherapy
Carboplatin-Taxol-Radiotherapy
Drug: Carboplatin-Taxol-Radiotherapy

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


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

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00198367     History of Changes
Other Study ID Numbers: IFCT-0101
First Submitted: September 13, 2005
First Posted: September 20, 2005
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Vinorelbine
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs