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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683514
• Other study ID #: PM 0259 CA 304 J1
• 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. 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

• Carcinoma, Non-Small-Cell Lung
• NSCLC

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