Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

September 13, 2005
March 9, 2016
May 2001
December 2009   (final data collection date for primary outcome measure)
Compare 3-Years survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Compare 3-Years survival
Complete list of historical versions of study NCT00198354 on ClinicalTrials.gov Archive Site
Compare Objective response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Compare Objective response rate
Not Provided
Not Provided
 
Stage I/II NSCLC Perioperative Chemotherapy
Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC
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.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-small Cell Lung Cancer Stage I and II
  • Peri-operative Chemotherapy
  • Drug: gemcitabine + cisplatine
    gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
  • Drug: Paclitaxel + Carboplatine
    paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
  • Experimental: A: pre-operative chemotherapy
    pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
    Intervention: Drug: gemcitabine + cisplatine
  • Experimental: B: pre-operative chemotherapy
    pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
    Intervention: Drug: gemcitabine + cisplatine
  • Experimental: C: peri-operative chemotherapy
    peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
    Intervention: Drug: Paclitaxel + Carboplatine
  • Experimental: D: peri-operative chemotherapy
    peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
    Intervention: Drug: Paclitaxel + Carboplatine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
530
December 2010
December 2009   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00198354
IFCT-0002
Yes
Undecided
Not Provided
Intergroupe Francophone de Cancerologie Thoracique
Intergroupe Francophone de Cancerologie Thoracique
Not Provided
Principal Investigator: Alain Depierre, Pr IFCT
Intergroupe Francophone de Cancerologie Thoracique
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP