Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(The study was terminated due to too slow recruitment)
Information provided by (Responsible Party):
European Lung Cancer Working Party Identifier:
First received: April 15, 2008
Last updated: February 11, 2015
Last verified: February 2015
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.

Condition Intervention Phase
Non Small Cell Lung Carcinoma
Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:
  • Survival [ Time Frame: Survival will be dated from the day of registration until death or last follow up ]

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

Enrollment: 75
Study Start Date: January 2007
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00661011

Department of Pneumology RHMS Hôpital de la Madeleine
Ath, Belgium, 7800
Department of Pneumology CHR St Joseph-Warquignies
Boussu, Belgium, 7360
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
Department of Pneumology Hospital Ixelles-Molière
Brussels, Belgium
Department of Pneumology CHU Charleroi
Charleroi, Belgium, 6000
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium, 6060
Hôpital Ambroise Paré
Mons, Belgium, 7000
Hôpital Vésale - Montigny-le-Tilleul
Montigny-le-Tilleul, Belgium, 6110
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, Belgium, 7700
CH Peltzer-La Tourelle
Verviers, Belgium, 4800
Medical Oncology St Savas Hospital
Athens, Greece, 11522
Medical Oncology Hospital de Sagunto
Valencia, Spain
Sponsors and Collaborators
European Lung Cancer Working Party
Study Chair: Jean-Paul Sculier, MD, PhD European Lung Cancer Working Party
  More Information

Responsible Party: European Lung Cancer Working Party Identifier: NCT00661011     History of Changes
Other Study ID Numbers: ELCWP 01061
Study First Received: April 15, 2008
Last Updated: February 11, 2015

Keywords provided by European Lung Cancer Working Party:
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents processed this record on May 25, 2017