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

NCT00683514 | Completed Phase 3

• 1 other identifier: PM 0259 CA 304 J1
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

A

OTHER

* 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)

B

OTHER

* 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)

Interventions

Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose) DRUG

q 28 days : * 50 mg/m2 oral vinorelbine d1, d8, d15 * 20 mg/m2/d cisplatin from d1 to d4

A; B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead
• Pierre Fabre Pharma GmbH: collaborator

Study Sites (1)

Pierre Fabre Pharma GmbH

Freiburg im Breisgau, Jechtinger Str. 13, D-79111, Germany

Location

MeSH Terms

Interventions

Vinorelbine; Cisplatin

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Marcello RIGGI, Clinical Development Director

  Institut de Recherche Pierre Fabre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: April 1, 2005
• Primary Completion: September 1, 2011
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

DE (1)