This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small cell lung cancer (NSCLC). The primary objective is to compare progression-free survival in both arms, the secondary is to evaluate the response rate, overall survival in both arms, to evaluate the safety profile in both arms and to assess quality of life by the LCSS questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
q 28 days : * 50 mg/m2 oral vinorelbine d1, d8, d15 * 20 mg/m2/d cisplatin from d1 to d4
q 21 days : * 60 mg/m2 oral vinorelbine d1,d8 for cycle 1 or 80 mg/m2 oral vinorelbine d1,d8 for cycle 2 * 80 mg/m2 cisplatin d1
Pierre Fabre Pharma GmbH
Freiburg im Breisgau, Jechtinger Str. 13, Germany
Assessments of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria
Time frame: at baseline and every 2 treatment cycles and Regular Follow Up at 2 months intervals during the 1st year after completion of treatment and then every 3 months until progression of the last evaluable patient
Assessment of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria, LCSS QOL Questionnaire and Physical Examination
Time frame: At baseline and every 2 treatment cycles, Regular follow up at 2 months intervals during 1 year and then every 3 months
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