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

Primary Purpose

Non Small Cell Lung Carcinoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lobectomy followed by concomitant mediastinal chemoradiotherapy
Sponsored by
European Lung Cancer Working Party
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Carcinoma focused on measuring Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Vinorelbine, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma, Surgery, Unresectable stage III non-small cell lung carcinoma not suitable for radical radiotherapy after objective response to induction chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pneumology RHMS Hôpital de la Madeleine
  • Department of Pneumology CHR St Joseph-Warquignies
  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
  • Department of Pneumology Hospital Ixelles-Molière
  • Department of Pneumology CHU Charleroi
  • Department of Pneumology Hôpital Saint-Joseph
  • Hôpital Ambroise Paré
  • Hôpital Vésale - Montigny-le-Tilleul
  • Department of Pneumology Centre Hospitalier de Mouscron
  • CH Peltzer-La Tourelle
  • Medical Oncology St Savas Hospital
  • Medical Oncology Hospital de Sagunto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Lobectomy followed by mediastinal concomitant chemoradiotherapy

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Operative mortality and morbidity
Local control rate
Toxicity

Full Information

First Posted
April 15, 2008
Last Updated
February 11, 2015
Sponsor
European Lung Cancer Working Party
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1. Study Identification

Unique Protocol Identification Number
NCT00661011
Brief Title
Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy
Official Title
A Phase II Study Assessing the Curative Effect of the Combination of Lobectomy Followed by Mediastinal Concomitant Radiochemotherapy in Patients With Locally Advanced Unresectable Stage III Non-small Cell Lung Cancer Responding to Induction Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to too slow recruitment
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Lung Cancer Working Party

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Carcinoma
Keywords
Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Vinorelbine, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma, Surgery, Unresectable stage III non-small cell lung carcinoma not suitable for radical radiotherapy after objective response to induction chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Lobectomy followed by mediastinal concomitant chemoradiotherapy
Intervention Type
Procedure
Intervention Name(s)
Lobectomy followed by concomitant mediastinal chemoradiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Survival
Time Frame
Survival will be dated from the day of registration until death or last follow up
Secondary Outcome Measure Information:
Title
Operative mortality and morbidity
Time Frame
To be observed during the 30 days following the surgical procedure
Title
Local control rate
Time Frame
After completion of treatment
Title
Toxicity
Time Frame
After each course of chemotherapy and at the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Sculier, MD, PhD
Organizational Affiliation
European Lung Cancer Working Party
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pneumology RHMS Hôpital de la Madeleine
City
Ath
ZIP/Postal Code
7800
Country
Belgium
Facility Name
Department of Pneumology CHR St Joseph-Warquignies
City
Boussu
ZIP/Postal Code
7360
Country
Belgium
Facility Name
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Department of Pneumology Hospital Ixelles-Molière
City
Brussels
Country
Belgium
Facility Name
Department of Pneumology CHU Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Department of Pneumology Hôpital Saint-Joseph
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Hôpital Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Hôpital Vésale - Montigny-le-Tilleul
City
Montigny-le-Tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
Department of Pneumology Centre Hospitalier de Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
Facility Name
CH Peltzer-La Tourelle
City
Verviers
ZIP/Postal Code
4800
Country
Belgium
Facility Name
Medical Oncology St Savas Hospital
City
Athens
ZIP/Postal Code
11522
Country
Greece
Facility Name
Medical Oncology Hospital de Sagunto
City
Valencia
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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