Stage I/II NSCLC Perioperative Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00198354
First received: September 13, 2005
Last updated: March 9, 2016
Last verified: March 2016
  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 + cisplatine
Drug: Paclitaxel + Carboplatine
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:


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

Primary Outcome Measures:
  • Compare 3-Years survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare Objective response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 530
Study Start Date: May 2001
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: pre-operative chemotherapy
pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
Drug: gemcitabine + cisplatine
gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
Experimental: B: pre-operative chemotherapy
pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
Drug: gemcitabine + cisplatine
gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
Experimental: C: peri-operative chemotherapy
peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
Drug: Paclitaxel + Carboplatine
paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
Experimental: D: peri-operative chemotherapy
peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
Drug: Paclitaxel + Carboplatine
paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)

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   (Adult, Senior)
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
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: NCT00198354

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

Additional Information:
Publications:

Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00198354     History of Changes
Other Study ID Numbers: IFCT-0002 
Study First Received: September 13, 2005
Last Updated: March 9, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
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 July 24, 2016