title: [A phase II study of weekly cisplatine plus oral vinorelbine with concomittant radiotherapy in non-dependent elderly patients with localized inoperable non small cell lung carcinoma (Essai GFPC 08-06, Raccosa)].
abstract: A phase II study of weekly cisplatine plus oral vinorelbine with concomittant radiotherapy in non-dependent elderly patients with localized inoperable non small cell lung carcinoma (Essai GFPC 08-06, Raccosa).
  
  
  BACKGROUND
  Non small cell lung cancer (NSCLC) in elderly patients is an important problem because of the increasing incidence of NSCLC and the aging of the population. Elderly patients constitute a heterogeneous population including a significant group of relatively fit patients who ought to benefit from the conventional treatment. The standard treatment for a locally advanced NSCLC (inoperable IIIA and IIIB) is concomitant radiochemotherapy, however studies evaluating this treatment to the old subject are few.
  
  
  METHODS
  This phase II study aims to evaluate tolerance of concomitant radiochemotherapy in fit elderly patients (more than 70 years old) with locally advanced NSCLC (inoperable IIIAN2 or IIIB). The treatment is oral vinorelbine (30 mg/m(2) per week) and intravenous cisplatine (30 mg/m(2) per week) during 6 weeks in conjunction with radiotherapy (66 Gy, 33 fraction, six and a half weeks). The main criterion of evaluation is acute toxicity. Late toxicity, quality of life, global response, time to progression and overall survival will also be estimated. With a Simon's optimal plan in two steps, the total number of patients to be included is 59 with an intermediate analysis after the inclusion of 19 patients.
  
  
  RESULTS
  Our study aims to demonstrate that fit elderly patients can benefit from concomitant radiochemotherapy. It will permit an improvement in the care available for fit elderly patients with locally advanced NSCLC by allowing them to benefit from the reference treatment.
authors.affiliation: Unité de Chimiothérapie Ambulatoire, Service de Pneumologie, Centre Hospitalier de Meaux, 6-8 rue Saint-Fiacre, 77100 Meaux, France. ch-locher@ch-meaux.fr
authors.forename: C
authors.initials: C
authors.lastname: Locher
authors.forename: N
authors.initials: N
authors.lastname: Pourel
authors.forename: B
authors.initials: B
authors.lastname: Marin
authors.forename: A
authors.initials: A
authors.lastname: Vergnenègre
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D009367:Neoplasm Staging; D011788:Quality of Life; D011879:Radiotherapy Dosage; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine