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)
Sponsor:
Information provided by:
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT00661011
First received: April 15, 2008
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Operative mortality and morbidity [ Time Frame: To be observed during the 30 days following the surgical procedure ] [ Designated as safety issue: Yes ]
  • Local control rate [ Time Frame: After completion of treatment ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2007
Estimated Study Completion Date: June 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00661011

Locations
Belgium
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
Greece
Medical Oncology St Savas Hospital
Athens, Greece, 11522
Spain
Medical Oncology Hospital de Sagunto
Valencia, Spain
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
Study Chair: Jean-Paul Sculier, MD, PhD European Lung Cancer Working Party
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Thierry Berghmans, European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00661011     History of Changes
Other Study ID Numbers: ELCWP 01061
Study First Received: April 15, 2008
Last Updated: April 27, 2010
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Spain: Ministry of Health
Greece: Ministry of Health and Welfare

Keywords provided by European Lung Cancer Working Party:
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014