Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III NSCLC responding to induction chemotherapy but in which the residual disease is too large to be treated by radiotherapy.

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Detailed Description

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Conditions

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Non Small Cell Lung Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Lobectomy followed by mediastinal concomitant chemoradiotherapy

Group Type EXPERIMENTAL

Lobectomy followed by concomitant mediastinal chemoradiotherapy

Intervention Type PROCEDURE

Lobectomy Radiotherapy 66 Gy in 2 Gy/ fraction, 5 fractions/wk Chemotherapy Cisplatin 60 mg/m² on days 1 and 22 and Vinorelbine 15 mg/m² on days 1, 8, 22 and 29

Interventions

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Lobectomy followed by concomitant mediastinal chemoradiotherapy

Lobectomy Radiotherapy 66 Gy in 2 Gy/ fraction, 5 fractions/wk Chemotherapy Cisplatin 60 mg/m² on days 1 and 22 and Vinorelbine 15 mg/m² on days 1, 8, 22 and 29

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological diagnosis of non-small cell carcinoma of the lung
* Initially stage III NSCLC
* Pathologically proven N2 or N3 disease
* Any response to induction chemotherapy (whatever the regimen administered)
* Disease still not fully resectable (because of extensive mediastinal N disease) and not suitable for radical radiotherapy (single field) after induction chemotherapy
* Lobectomy possible for the treatment of T disease
* Availability for participating in the detailed follow-up of the protocol
* Informed consent

Exclusion Criteria

* Prior treatment with radiotherapy or surgery
* Karnofsky PS \< 60
* Functional or anatomical contra-indication to mediastinal radiotherapy
* Functional or anatomical contra-indication to surgical lobectomy
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
* Malignant pleural or pericardial effusion
* Neutrophils \< 2,000/mm³
* Platelet cells \< 100,000/mm3
* Serum bilirubin \> 1.5 mg/100 ml
* Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min
* Recent myocardial infarction (less than 3 months prior to date of diagnosis)
* Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
* Uncontrolled infectious disease
* Hearing loss
* Symptomatic polyneuropathy
* Serious medical or psychological factors which may prevent adherence to the treatment schedule

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No