Trial Information

Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemotherapy With Cisplatin-docetaxel in Patients With Locally Advanced Non-small-cell Lung Cancer. A Multicenter Phase II Trial

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.