Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Oral Vinorelbine And Cisplatin With Concomitant Radiotherapy Followed By Either Consolidation Therapy With Oral Vinorelbine And Cisplatin Plus Best Supportive Care Or Best Supportive Care Alone In Stage III Non Small Cell Lung Cancer (NSCLC), A Randomized Phase III Study

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
* Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Presence of at least one measurable lesion (RECIST criteria) Patients with a Karnofsky Performance Status = or > 80% Adequate pulmonary function, bone marrow, hepatic and renal functions Main Exclusion Criteria: Patients with NSCLC stage IV, with NSCLC stages I, II, IIIA (except N2), with NSCLC stage IIIB with tumour extent or pleural effusion Symptomatic neuropathy > Grade 1 Hearing impairment = or > Grade 2 Concomitant/uncontrolled medical disorder Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>cycle 1 & 2 (q 28 days) = chemotherapy : oral vinorelbine (50 mg/m2 d1, d8, d15) and cisplatin (20 mg/m2/d from d1 to d4) combined with radiotherapy cycle 3 & 4 (q 21 days) = chemotherapy : oral vinorelbine (60 mg/m2 d1, d8 for cycle 1, 80 mg/m2 d1 & d8 for cycle 2) and cisplatin (80 mg/m2 d1) plus Best Supportive Care | Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)<br>* q 28 days : 50 mg/m2 oral vinorelbine d1, d8, d15 20 mg/m2/d cisplatin from d1 to d4<br>Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)<br>* 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<br>|
| Other: B<br>cycle 1 & 2 (q 28 days) = chemotherapy : oral vinorelbine (50 mg/m2 d1, d8, d15) and cisplatin (20 mg/m2/d from d1 to d4) combined with radiotherapy Best Supportive Care only | Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)<br>* q 28 days : 50 mg/m2 oral vinorelbine d1, d8, d15 20 mg/m2/d cisplatin from d1 to d4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | At baseline and every 2 treatment cycles, Regular follow up at 2 months intervals during 1 year and then every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Untreated locally advanced inoperable stage IIIA or stage IIIB NSCLC amenable to radical radiotherapy to a dose of 66 Gy