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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Pierre Fabre Medicament.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pierre Fabre Pharma GmbH
Information provided by:
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT00683514
First received: May 21, 2008
Last updated: May 22, 2008
Last verified: May 2008

May 21, 2008
May 22, 2008
April 2005
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00683514 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
NSCLC
  • 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
  • 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
    Interventions:
    • Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
    • Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
  • 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
    Intervention: Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
Not Provided
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
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
Germany
 
NCT00683514
PM 0259 CA 304 J1
No
Marcello RIGGI, MD, Institut de Recherche Pierre Fabre
Pierre Fabre Medicament
Pierre Fabre Pharma GmbH
Study Director: Marcello RIGGI, Clinical Development Director Institut de Recherche Pierre Fabre
Pierre Fabre Medicament
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP