Chemoradiotherapy of NSCLC Stage IIIB

Phase 2CompletedNCT00198432

Intergroupe Francophone de Cancerologie Thoracique130 enrolled

Overview

To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

Chemotherapy: C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m² Radiotherapy: 66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (\>= 9MV)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

NSCLC Stage IIIB Concomitant Radiochemotherapy

Interventions

Paclitaxel, vinorelbine, cisplatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural * PS = 0 or 1 * Possibility of including all the targets in only one exposure field * Slimming \< 10% of the weight of the body * Functions hepatic, renal and hematologic normal * VEMS \>40% and PaO2 \>60 mmHg * written and signed informed consent Exclusion criteria : \- NSCLC stage IV or wet-IIIB

Locations (1)

CHU Saint-Etienne Pneumologie

Saint-Etienne, France

Outcomes

Primary Outcomes

Objective response rate

Secondary Outcomes

Overall survival

Time to progression

Relapse rate (local control)

Safety

Data from ClinicalTrials.gov

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