Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemotherapy in Locally Advanced NSCLC.
Condition: Lung Neoplasm
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Our aim is to conducted a multicenter phase II trial of the cisplatin-oral vinorelbine
      -radiotherapy combination after induction chemotherapy with cisplatin-docetaxel in patient
      with NSCLC. Oral vinorelbine will be used in the present study rather than the intravenous
      form because: 1- Previous investigations have demonstrated that oral vinorelbine is as
      effective as the intravenous form in the treatment of NSCLC. 2 - We think that the use of
      oral agents in CT will reduce some disagreements provoked by intravenous injections: stress,
      infections, hemorrhage, displacement at the hospital and cost of CT.

      .
    

Detailed description: 
      About one-third of patients with non-small-cell lung cancer (NSCLC) have inoperable, locally
      advanced stage III disease at diagnosis. The most satisfactory treatment for patients with
      locally advanced NSCLC is combination chemotherapy-radiotherapy (CT-RT). However, the optimal
      interval between irradiation and chemotherapy as well as the most effective chemotherapy
      protocol remains to be defined.

      Our aim is to conducted a multicenter phase II trial of the cisplatin-oral vinorelbine
      -radiotherapy combination after induction chemotherapy with cisplatin-docetaxel in patient
      with NSCLC. Oral vinorelbine will be used in the present study rather than the intravenous
      form because: 1- Previous investigations have demonstrated that oral vinorelbine is as
      effective as the intravenous form in the treatment of NSCLC. 2 - We think that the use of
      oral agents in CT will reduce some disagreements provoked by intravenous injections: stress,
      infections, hemorrhage, displacement at the hospital and cost of CT.

      Patients will be enrolled in the study by members of GFPC, a French cooperative group on
      thoracic oncology. The main eligibility criteria are : histologically or cytologically
      documented inoperable stage IIIA N2 or IIIB NSCLC previously untreated, absence of malignant
      pleural effusion, performance status (PS) =1 and patient life expectancy of at least 12
      weeks. Induction chemotherapy will comprise two cycles of cisplatin 80mg/m2 and docetaxel
      75mg/m2 (given on D1 and D22). Concomitant CT-RT will start on D57. Radiotherapy will occur
      from D57 until D99 (2 Gy/day, 5 days/week, total dose is 66 Gy). Cisplatin 80mg/m2 will be
      given on D57 (first day of irradiation) and D78. Oral vinorelbine 40 mg/m2 will be
      administered on D57, D64, D78 and D85. The main endpoint is the objective response rate. The
      tumor response will be assessed first at the end of induction chemotherapy, and again 4 weeks
      after concurrent CT-RT. Patients who will progress after induction chemotherapy will leave
      the study. Those with stable disease or a tumor response will receive the CT-RT combination.
      Tolerability, time until progression, duration of response and proportion of survival at 1, 2
      and 3 years represent a secondary endpoints. The study will be achieved according to the
      French legislation and guidelines for biomedical research involving human subjects.
    

Intervention name(s): Vinorelbine
Intervention type(s): Drug
Intervention MeSH terms: Vinorelbine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Small-Cell Lung,radiotherapy, Chemotherapy, vinorelbine