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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00683514
Other study ID # PM 0259 CA 304 J1
Secondary ID
Status Completed
Phase Phase 3
First received May 21, 2008
Last updated October 3, 2016
Start date April 2005

Study information

Verified date October 2016
Source Pierre Fabre Medicament
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Germany Pierre Fabre Pharma GmbH Freiburg Jechtinger Str. 13

Sponsors (2)

Lead Sponsor Collaborator
Pierre Fabre Medicament Pierre Fabre Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
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