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Stage I/II NSCLC Perioperative Chemotherapy

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Bristol-Myers Squibb
Information provided by:
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00198354
First received: September 13, 2005
Last updated: March 26, 2008
Last verified: December 2005
History of Changes
  Purpose

The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.


Condition Intervention Phase
Non-Small Cell Lung Cancer Stage I and II
Peri-Operative Chemotherapy
 Drug: gemcitabine, paclitaxel, cisplatin, carbopatine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Compare 3-Years survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Compare Objective response rate [ Time Frame: 6 weeks ]

Enrollment: 530
Study Start Date: May 2001
Estimated Study Completion Date: December 2008
Detailed Description:

In this multicenter study, patients are randomized to receive either two preoperative chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy, or two preoperative plus two postoperative cycles in case of response.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less

Exclusion Criteria:

NSCLC stage III or IV

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198354

Locations
France
CHU Besancon - Pneumologie
Besancon, France, 25000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Eli Lilly and Company
Bristol-Myers Squibb
Investigators
Principal Investigator: Alain Depierre, Pr IFCT
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00198354     History of Changes
Other Study ID Numbers: IFCT-0002
Study First Received: September 13, 2005
Last Updated: March 26, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013