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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

* 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

Group Type OTHER

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

Intervention Type DRUG

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)

Intervention Type DRUG

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

B

* 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

Group Type OTHER

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

Intervention Type DRUG

q 28 days :

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No