title: [How to treat the relapse of NSCLC after surgery and chemotherapy? IFTC 0702 randomized phase III study].
abstract: 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.
authors.affiliation: PMAC Clinique de Pneumologie, CHU de Grenoble, France. DMoro.pneumo@chu-grenoble.fr
authors.forename: D
authors.initials: D
authors.lastname: Moro-Sibilot
authors.forename: F
authors.initials: F
authors.lastname: Barlesi
authors.forename: J F
authors.initials: JF
authors.lastname: Timsit
authors.forename: D
authors.initials: D
authors.lastname: Debieuvre
authors.forename: P
authors.initials: P
authors.lastname: Fournel
authors.forename: R
authors.initials: R
authors.lastname: Gervais
authors.forename: J
authors.initials: J
authors.lastname: Mazieres
authors.forename: B
authors.initials: B
authors.lastname: Milleron
authors.forename: F
authors.initials: F
authors.lastname: Morin
authors.forename: M
authors.initials: M
authors.lastname: Perol
authors.forename: J C
authors.initials: JC
authors.lastname: Soria
authors.forename: P J
authors.initials: PJ
authors.lastname: Souquet
authors.forename: A
authors.initials: A
authors.lastname: Vergnenègre
authors.forename: G
authors.initials: G
authors.lastname: Zalcman
mesh_terms: 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*
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin