[How to treat the relapse of NSCLC after surgery and chemotherapy? IFTC 0702 randomized phase III study].
BACKGROUND
As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC, particularly in the adjuvant and neoadjuvant setting, physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy. The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined. The current study has been designed to compare the classical mono chemotherapy docetaxel with a docetaxel cisplatin doublet.


METHODS
Patients will be randomized in 2 arms. Arm: docetaxel cisplatin (cycles repeated every 21 days), 4 cycles followed by 2 cycles of docetaxel alone in case of objective response or stabilisation. Arm B: docetaxel alone (cycles repeated every 21 days), 4 cycles followed by 2 cycles of docetaxel alone in case of objective response or stabilisation.


RESULTS
300 patients will be randomized with a statistical hypothesis of a progression free survival of 3 months in the control arm and of 4.5 months in the experimental arm.
Moro-Sibilot
D
D
PMAC Clinique de Pneumologie, CHU de Grenoble, France. DMoro.pneumo@chu-grenoble.fr
Barlesi
F
F
Timsit
J F
JF
Debieuvre
D
D
Fournel
P
P
Gervais
R
R
Mazieres
J
J
Milleron
B
B
Morin
F
F
Perol
M
M
Soria
J C
JC
Souquet
P J
PJ
Vergnenègre
A
A
Zalcman
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000628:therapy; D002945:Cisplatin / Q000008:administration & dosage*; D000077143:Docetaxel; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000628:therapy; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D043823:Taxoids / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin