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:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00198367
First received: September 13, 2005
Last updated: May 10, 2016
Last verified: May 2016
  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
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:


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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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, see Learn About Clinical Studies.

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

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00198367     History of Changes
Other Study ID Numbers: IFCT-0101 
Study First Received: September 13, 2005
Last Updated: May 10, 2016
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:
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
Vinorelbine
Gemcitabine
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

ClinicalTrials.gov processed this record on August 24, 2016