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

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

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 Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose); Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Jechtinger Str. 13
    • Freiburg, Jechtinger Str. 13, Germany, D-79111
      • Pierre Fabre Pharma GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: A; 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); q 28 days : 50 mg/m2 oral vinorelbine d1, d8, d15; 20 mg/m2/d cisplatin from d1 to d4; Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose); 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
OTHER: B; 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); q 28 days : 50 mg/m2 oral vinorelbine d1, d8, d15; 20 mg/m2/d cisplatin from d1 to d4; Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament
• Collaborators: Pierre Fabre Pharma GmbH
• Investigators: Study Director: Marcello RIGGI, Clinical Development Director, Institut de Recherche Pierre Fabre

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: May 21, 2008
• First Submitted That Met QC Criteria: May 22, 2008
• First Posted (ESTIMATE): May 23, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Untreated locally advanced inoperable stage IIIA or stage IIIB NSCLC amenable to radical radiotherapy to a dose of 66 Gy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Cisplatin; Vinorelbine
• Other Study ID Numbers: PM 0259 CA 304 J1