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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683514
First Posted: May 23, 2008
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pierre Fabre Pharma GmbH
Information provided by (Responsible Party):
Pierre Fabre Medicament
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • 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 [ Time Frame: At baseline and every 2 treatment cycles, Regular follow up at 2 months intervals during 1 year and then every 3 months ]

Enrollment: 201
Study Start Date: April 2005
Primary Completion Date: September 2011 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683514


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

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT00683514     History of Changes
Other Study ID Numbers: PM 0259 CA 304 J1
First Submitted: May 21, 2008
First Posted: May 23, 2008
Last Update Posted: October 4, 2016
Last Verified: October 2016

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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin
Vinblastine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action