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

Pierre Fabre

Status and phase: Completed; Phase 3

Conditions: NSCLC

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683514

PM 0259 CA 304 J1

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

A

Other group

Description:

* 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

Treatment:

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

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

B

Other group

Description:

* 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

Treatment:

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

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