Non-small Cell Lung Cancer Stage I and II, Peri-operative Chemotherapy
Conditions
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.
Interventions
gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
Sponsors
Intergroupe Francophone de Cancerologie Thoracique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare 3-Years survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Compare Objective response rate | 6 weeks |
Countries
France
Outcome results
None listed