Chemoradiotherapy of NSCLC Stage IIIB

Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198432

Enrollment

130

Registered

2005-09-20

Start date

2002-03-31

Completion date

2006-12-31

Last updated

2016-03-10

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

Conditions

Concomitant Radiochemotherapy, NSCLC Stage IIIB

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)

Interventions

DRUGPaclitaxel, vinorelbine, cisplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Objective response rate	—

Secondary

Measure	Time frame
Overall survival	—
Time to progression	—
Relapse rate (local control)	—
Safety	—

Countries

France

Outcome results

None listed

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