- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00661011
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
Status
Terminated
Conditions
Intervention / Treatment
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
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Ath, Belgium, 7800
- Department of Pneumology RHMS Hôpital de la Madeleine
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Boussu, Belgium, 7360
- Department of Pneumology CHR St Joseph-Warquignies
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Brussels, Belgium, 1000
- Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
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Brussels, Belgium
- Department of Pneumology Hospital Ixelles-Molière
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Charleroi, Belgium, 6000
- Department of Pneumology CHU Charleroi
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Gilly, Belgium, 6060
- Department of Pneumology Hôpital Saint-Joseph
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Mons, Belgium, 7000
- Hopital Ambroise Pare
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Montigny-le-Tilleul, Belgium, 6110
- Hôpital Vésale - Montigny-le-Tilleul
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Mouscron, Belgium, 7700
- Department of Pneumology Centre Hospitalier de Mouscron
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Verviers, Belgium, 4800
- CH Peltzer-La Tourelle
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Athens, Greece, 11522
- Medical Oncology St Savas Hospital
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Valencia, Spain
- Medical Oncology Hospital de Sagunto
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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 |
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Experimental: A
Lobectomy followed by mediastinal concomitant chemoradiotherapy
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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
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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
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Survival will be dated from the day of registration until death or last follow up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity
Time Frame: After each course of chemotherapy and at the end of treatment
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After each course of chemotherapy and at the end of treatment
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Local control rate
Time Frame: After completion of treatment
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After completion of treatment
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Operative mortality and morbidity
Time Frame: To be observed during the 30 days following the surgical procedure
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To be observed during the 30 days following the surgical procedure
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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
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
Other Study ID Numbers
- ELCWP 01061
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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