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

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

• Status: Terminated
• Conditions: Non Small Cell Lung Carcinoma
• Intervention / Treatment: Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • 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
    • Hôpital Ambroise Paré
  • 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
• Greece
  • Athens, Greece, 11522
    • Medical Oncology St Savas Hospital
• Spain
  • Valencia, Spain
    • Medical Oncology Hospital de Sagunto

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: European Lung Cancer Working Party

Study record dates

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

Terms related to this study

• Keywords: Surgery; Cisplatin; Radiotherapy; Chemotherapy; Vinorelbine; Non-small cell lung carcinoma; Concomitant radiochemotherapy; Unresectable stage III non-small cell lung carcinoma; Unresectable stage III non-small cell lung carcinoma not suitable for radical radiotherapy after objective response to induction chemotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma
• Other Study ID Numbers: ELCWP 01061