Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC
Overview
- Phase
- Phase 3
- Intervention
- gemcitabine + cisplatine
- Conditions
- Non-small Cell Lung Cancer Stage I and II
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Enrollment
- 530
- Locations
- 1
- Primary Endpoint
- Compare 3-Years survival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
A: pre-operative chemotherapy
pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
Intervention: gemcitabine + cisplatine
B: pre-operative chemotherapy
pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
Intervention: gemcitabine + cisplatine
C: peri-operative chemotherapy
peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
Intervention: Paclitaxel + Carboplatine
D: peri-operative chemotherapy
peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
Intervention: Paclitaxel + Carboplatine
Outcomes
Primary Outcomes
Compare 3-Years survival
Time Frame: 3 years
Secondary Outcomes
- Compare Objective response rate(6 weeks)