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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00683514

Enrollment

201

Registered

2008-05-23

Start date

2005-04-30

Completion date

Unknown

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Keywords

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

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.

Interventions

DRUGOral 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026