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

February 11, 2015 updated by: European Lung Cancer Working Party

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ath, Belgium, 7800
        • Department of Pneumology RHMS Hôpital de la Madeleine
      • Boussu, Belgium, 7360
        • Department of Pneumology CHR St Joseph-Warquignies
      • Brussels, Belgium, 1000
        • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
      • Brussels, Belgium
        • Department of Pneumology Hospital Ixelles-Molière
      • Charleroi, Belgium, 6000
        • Department of Pneumology CHU Charleroi
      • Gilly, Belgium, 6060
        • Department of Pneumology Hôpital Saint-Joseph
      • Mons, Belgium, 7000
        • Hopital Ambroise Pare
      • Montigny-le-Tilleul, Belgium, 6110
        • Hôpital Vésale - Montigny-le-Tilleul
      • Mouscron, Belgium, 7700
        • Department of Pneumology Centre Hospitalier de Mouscron
      • Verviers, Belgium, 4800
        • CH Peltzer-La Tourelle
      • Athens, Greece, 11522
        • Medical Oncology St Savas Hospital
      • Valencia, Spain
        • Medical Oncology Hospital de Sagunto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Lobectomy followed by mediastinal concomitant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: Survival will be dated from the day of registration until death or last follow up
Survival will be dated from the day of registration until death or last follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: After each course of chemotherapy and at the end of treatment
After each course of chemotherapy and at the end of treatment
Local control rate
Time Frame: After completion of treatment
After completion of treatment
Operative mortality and morbidity
Time Frame: To be observed during the 30 days following the surgical procedure
To be observed during the 30 days following the surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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