Chemoradiotherapy of NSCLC Stage IIIB

Phase 2

Completed

• Conditions: Concomitant Radiochemotherapy; NSCLC Stage IIIB

• Registration Number: NCT00198432
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Completion: 2006-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective response rate

Secondary Outcome Measures

Name	Time	Method
Overall survival
Time to progression
Relapse rate (local control)
Safety

Trial Locations

Locations (1)

CHU Saint-Etienne Pneumologie; 🇫🇷 Saint-Etienne, France