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:
European Lung Cancer Working Party
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
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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
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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013