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

Sponsor:	Pierre Fabre Medicament
Collaborator:	Pierre Fabre Pharma GmbH
Information provided by:	Pierre Fabre Medicament
ClinicalTrials.gov Identifier:	NCT00683514

Purpose

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.

Condition	Intervention	Phase
NSCLC	Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate

U.S. FDA Resources

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assessment of mesurable 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	360
Study Start Date:	April 2005
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683514

Contacts

Contact: Johannes EISINGER, MD	49-761-45261-851	johannes.eisinger@pierre-fabre.de
Contact: Susanne OSOWSKI, CRA	49-761-45261-853	susanne.osowski@pierre-fabre.de

Locations

Germany
Pierre Fabre Pharma GmbH	Recruiting
Freiburg, Jechtinger Str. 13, Germany, D-79111
Contact: Johannes EISINGER, MD 49-761-45261-851 johannes.eisinger@pierre-fabre.de
Contact: Susanne OSOWSKI, CRA 49-761-45261-853 susanne.osowski@pierre-fabre.de

Sponsors and Collaborators

Pierre Fabre Medicament

Pierre Fabre Pharma GmbH

Investigators

Study Director:

Marcello RIGGI, Clinical Development Director

Institut de Recherche Pierre Fabre

More Information

No publications provided

Responsible Party:	Marcello RIGGI, MD, Institut de Recherche Pierre Fabre
ClinicalTrials.gov Identifier:	NCT00683514 History of Changes
Other Study ID Numbers:	PM 0259 CA 304 J1
Study First Received:	May 21, 2008
Last Updated:	May 22, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pierre Fabre Medicament:

Untreated locally advanced inoperable stage IIIA or stage IIIB NSCLC amenable to radical radiotherapy to a dose of 66 Gy

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin

Vinblastine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012