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

NCT00683514 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2016-10-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Pierre Fabre Pharma GmbH

    collaborator INDUSTRY

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Marcello RIGGI, Clinical Development Director · Institut de Recherche Pierre Fabre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2011-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00683514 on ClinicalTrials.gov