Stage I/II NSCLC Perioperative Chemotherapy
- Conditions
- Non-small Cell Lung Cancer Stage I and IIPeri-operative Chemotherapy
- Interventions
- Registration Number
- NCT00198354
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 530
Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less
NSCLC stage III or IV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A: pre-operative chemotherapy gemcitabine + cisplatine pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles) B: pre-operative chemotherapy gemcitabine + cisplatine pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles) C: peri-operative chemotherapy Paclitaxel + Carboplatine peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles) D: peri-operative chemotherapy Paclitaxel + Carboplatine peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
- Primary Outcome Measures
Name Time Method Compare 3-Years survival 3 years
- Secondary Outcome Measures
Name Time Method Compare Objective response rate 6 weeks
Trial Locations
- Locations (1)
CHU Besancon - Pneumologie
🇫🇷Besancon, France