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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-GERCOR-B00-1 | |||
| EU-20330 |
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy regimen (conformational vs nonconformational).
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for up to 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 7-7.5 weeks. Three weeks after completion of chemoradiotherapy, patients with stable or responding disease are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 390 patients will be accrued for this study within 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| paclitaxel | Drug | |||
| adjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | ||
| Overall survival | ||
| Toxicity |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Measurable or evaluable disease
No T4 apical localization
Lesions able to be covered in a 60 Gy minimum volume of radiation
No pleural effusion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Jean F. Morere, MD | Hopital Avicenne |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Annecy | Annecy | 74011 Cedex | France | |||
| Institut Sainte Catherine |
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| Avignon |
| 84082 |
| France |
| Hopital Duffaut | Avignon | 84902 | France |
| Centre Hospitalier Bayeux | Bayeux | 14400 | France |
| Centre Hospitalier de la Cote Basque | Bayonne | 64100 | France |
| C.H.G. Beauvais | Beauvais | 60021 | France |
| Hopital Avicenne | Bobigny | 93009 | France |
| Clinique du Cedre | Bois-Guillaume | 76230 | France |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| Clinique Tivoli | Bordeaux | F-33000 | France |
| Polyclinique Bordeaux Nord Aquitaine | Boucher | 33300 | France |
| Polyclinique Du Parc Centre Maurice Tubiana | Caen | 14052 | France |
| Hopital Louis Pasteur | Chartres | 28018 | France |
| Centre d'Oncologie et de Radiotherapie de Chaumont le Bois | Chaumont | 52000 | France |
| Centre Hospitalier Chaumont | Chaumont | 52000 | France |
| Centre Hospitalier Chateaudun | Châteaudun | 28200 | France |
| Hopital Louis Pasteur | Comar | 68021 | France |
| Clinique des Cedres | Cornebarrieu | 31700 | France |
| Centre d'Oncologie et de Radiotherapie du Parc | Dijon | 21000 | France |
| Hopital Jean Monnet | Épinal | BP590 | France |
| Centre Hospitalier D'Evreux | Évreux | 27000 | France |
| Clinique Pasteur | Évreux | 27000 | France |
| Clinique du Petit Colmouilins | Harfleur | 76700 | France |
| Centre Mallet - Proux | Laval | 53000 | France |
| C.H.G Laval | Laval | 53024 | France |
| Centre Guillaume Le Conquerant | Le Havre | 76600 | France |
| Centre Jean Bernard | Le Mans | 72000 | France |
| C. H. Du Mans | Le Mans | 72037 | France |
| Centre Hospitalier General | Le Mans | 72037 | France |
| Hopital Robert Boulin | Libourne | 33500 | France |
| Clinique de le Louviere | Lille | F-59800 | France |
| Clinique Chenieux | Limoges | 87000 | France |
| Centre Hospitalier Robert Bisson | Lisieux | 14100 | France |
| Medipole Gentilly Saint-Jacques | Maxéville | 54320 | France |
| Hopital Notre-Dame de Bon Secours | Metz | 55038 | France |
| Clinique du Pont de Chaume | Montauban | 82017 | France |
| C.H. Du Havre | Montivilliers | F-76290 | France |
| Polyclinique Saint - Roch | Montpellier | 34000 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Clinique Clementville | Montpellier | France |
| Centre Hospitalier de Mulhouse | Mulhouse | 68051 | France |
| Centre D'Oncologie De Gentilly | Nancy | 54100 | France |
| Clinique De Valdegour | Nîmes | 30900 | France |
| CHR D'Orleans - Hopital de la Source | Orléans | 45100 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| Hopital Tenon | Paris | 75970 | France |
| C.H.G. De Pau | Pau | 64000 | France |
| Maison Medicale Marzet | Pau | 64000 | France |
| Clinique Saint - Pierre | Perpignan | France |
| Clinique les Bleuets | Reims | 51100 | France |
| Groupe Medical St. Remy | Reims | 51100 | France |
| Polyclinique De Courlancy | Reims | F-51100 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Centre Frederic Joliot | Rouen | 76000 | France |
| Centre Hospitalier de Saint - Brieuc | Saint-Brieuc | 22023 | France |
| Clinique Armoricaine De Radiologie | Saint-Brieuc | F-22015 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| Centre Hospitalier De Saint Dizier | Saint-Dizier | 52100 | France |
| Clinique Saint Vincent | Saint-Grégoire | 35700 | France |
| Clinique de l'Union | Saint-Jean | 31240 | France |
| Centre du Rouget | Sarcelles | 95250 | France |
| C. H. De Saumur | Saumur | 49403 | France |
| Clinique de l'Orangerie | Strasbourg | 67010 | France |
| Polyclinique de L'Ormeau | Tarbes | 65000 | France |
| Centre Hospitalier Regional Metz Thionville | Thionville | 57126 | France |
| Centre Hospitalier de Valenciennes | Valenciennes | 59300 | France |
| Clinique Medico Chirurgicale Teissier Groupe | Valenciennes | France |
| Centre Hospitalier De Vernon | Vernon | 27200 | France |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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