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The study was terminated due to too slow recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Lobectomy followed by mediastinal concomitant chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lobectomy followed by concomitant mediastinal chemoradiotherapy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival will be dated from the day of registration until death or last follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Operative mortality and morbidity | To be observed during the 30 days following the surgical procedure | |
| Local control rate | After completion of treatment | |
| Toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Sculier, MD, PhD | European Lung Cancer Working Party | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pneumology RHMS Hôpital de la Madeleine | Ath | 7800 | Belgium | |||
| Department of Pneumology CHR St Joseph-Warquignies |
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| Label | URL |
|---|---|
| (Click here for more information on the protocol) | View source |
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| After each course of chemotherapy and at the end of treatment |
| Boussu |
| 7360 |
| Belgium |
| Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet | Brussels | 1000 | Belgium |
| Department of Pneumology Hospital Ixelles-Molière | Brussels | Belgium |
| Department of Pneumology CHU Charleroi | Charleroi | 6000 | Belgium |
| Department of Pneumology Hôpital Saint-Joseph | Gilly | 6060 | Belgium |
| Hôpital Ambroise Paré | Mons | 7000 | Belgium |
| Hôpital Vésale - Montigny-le-Tilleul | Montigny-le-Tilleul | 6110 | Belgium |
| Department of Pneumology Centre Hospitalier de Mouscron | Mouscron | 7700 | Belgium |
| CH Peltzer-La Tourelle | Verviers | 4800 | Belgium |
| Medical Oncology St Savas Hospital | Athens | 11522 | Greece |
| Medical Oncology Hospital de Sagunto | Valencia | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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