Chemoradiotherapy of NSCLC Stage IIIB

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

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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NSCLC Stage IIIB Concomitant Radiochemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paclitaxel, vinorelbine, cisplatin

Intervention Type DRUG

Eligibility Criteria

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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