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

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ClinicalTrials.gov Identifier: NCT00661011
Recruitment Status : Terminated (The study was terminated due to too slow recruitment)
First Posted : April 18, 2008
Last Update Posted : February 12, 2015
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Primary Completion Date : December 2013
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00661011     History of Changes
Other Study ID Numbers: ELCWP 01061
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 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