Clinical trial NCT00683514: Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSCLC
Keywords: Untreated locally advanced inoperable stage IIIA or stage IIIB NSCLC amenable to radical radiotherapy to a dose of 66 Gy
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
Collaborators: name: Pierre Fabre Pharma GmbH
First posted: 2008-05-23
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Assessments of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria
timeFrame: 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:
measure: 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
timeFrame: At baseline and every 2 treatment cycles, Regular follow up at 2 months intervals during 1 year and then every 3 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Pierre Fabre Pharma GmbH
state: Jechtinger Str. 13
Study officials:
affiliation: Institut de Recherche Pierre Fabre
name: Marcello RIGGI, Clinical Development Director
role: STUDY_DIRECTOR
References: