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

Phase 3

Completed

• Conditions: NSCLC
• Interventions: Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)

• Registration Number: NCT00683514
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Primary Completion: 2011-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)	* 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
A	Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)	* 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pierre Fabre Pharma GmbH; 🇩🇪 Freiburg, Jechtinger Str. 13, Germany