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| Sponsor: | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077220 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer |
| Study Start Date: | June 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| France | |
| C. H. De Saumur | |
| Saumur, France, 49403 | |
| C. H. Du Mans | |
| Le Mans, France, 72037 | |
| C.H. Du Havre | |
| Montivilliers, France, F-76290 | |
| C.H.G Laval | |
| Laval, France, 53024 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| C.H.G. De Pau | |
| Pau, France, 64000 | |
| Centre D'Oncologie De Gentilly | |
| Nancy, France, 54100 | |
| Centre d'Oncologie et de Radiotherapie de Chaumont le Bois | |
| Chaumont, France, 52000 | |
| Centre d'Oncologie et de Radiotherapie du Parc | |
| Dijon, France, 21000 | |
| Centre du Rouget | |
| Sarcelles, France, 95250 | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 | |
| Centre Frederic Joliot | |
| Rouen, France, 76000 | |
| Centre Guillaume Le Conquerant | |
| Le Havre, France, 76600 | |
| Centre Hospitalier Bayeux | |
| Bayeux, France, 14400 | |
| Centre Hospitalier Chateaudun | |
| Chateaudun, France, 28200 | |
| Centre Hospitalier Chaumont | |
| Chaumont, France, 52000 | |
| Centre Hospitalier d'Annecy | |
| Annecy, France, 74011 Cedex | |
| Centre Hospitalier de la Cote Basque | |
| Bayonne, France, 64100 | |
| Centre Hospitalier de Mulhouse | |
| Mulhouse, France, 68051 | |
| Centre Hospitalier de Saint - Brieuc | |
| Saint-Brieuc, France, 22023 | |
| Centre Hospitalier De Saint Dizier | |
| Saint Dizier, France, 52100 | |
| Centre Hospitalier de Valenciennes | |
| Valenciennes, France, 59300 | |
| Centre Hospitalier De Vernon | |
| Vernon, France, 27200 | |
| Centre Hospitalier D'Evreux | |
| Evreux, France, 27000 | |
| Centre Hospitalier General | |
| Le Mans, France, 72037 | |
| Centre Hospitalier Regional Metz Thionville | |
| Thionville, France, 57126 | |
| Centre Hospitalier Robert Bisson | |
| Lisieux, France, 14100 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Centre Mallet - Proux | |
| Laval, France, 53000 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| CHR D'Orleans - Hopital de la Source | |
| Orleans, France, 45100 | |
| Clinique Armoricaine De Radiologie | |
| Saint Brieuc, France, F-22015 | |
| Clinique Chenieux | |
| Limoges, France, 87000 | |
| Polyclinique Saint - Roch | |
| Montpellier, France, 34000 | |
| Clinique de le Louviere | |
| Lille, France, F-59800 | |
| Clinique de l'Orangerie | |
| Strasbourg, France, 67010 | |
| Clinique de l'Union | |
| Saint Jean, France, 31240 | |
| Clinique De Valdegour | |
| Nimes, France, 30900 | |
| Clinique des Cedres | |
| Cornebarrieu, France, 31700 | |
| Clinique du Cedre | |
| Bois-Guillaume, France, 76230 | |
| Clinique du Petit Colmouilins | |
| Harfleur, France, 76700 | |
| Clinique du Pont de Chaume | |
| Montauban, France, 82017 | |
| Clinique les Bleuets | |
| Reims, France, 51100 | |
| Clinique Medico Chirurgicale Teissier Groupe | |
| Valenciennes, France | |
| Clinique Pasteur | |
| Evreux, France, 27000 | |
| Clinique Saint - Pierre | |
| Perpignan, France | |
| Clinique Saint Vincent | |
| Saint Gregoire, France, 35700 | |
| Clinique Tivoli | |
| Bordeaux, France, F-33000 | |
| Groupe Medical St. Remy | |
| Reims, France, 51100 | |
| Hopital Avicenne | |
| Bobigny, France, 93009 | |
| Hopital Duffaut | |
| Avignon, France, 84902 | |
| Hopital Jean Monnet | |
| Epinal, France, BP590 | |
| Hopital Louis Pasteur | |
| Chartres, France, 28018 | |
| Hopital Louis Pasteur | |
| Comar, France, 68021 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 55038 | |
| Hopital Robert Boulin | |
| Libourne, France, 33500 | |
| Hopital Saint Andre | |
| Bordeaux, France, 33075 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Institut Sainte Catherine | |
| Avignon, France, 84082 | |
| Maison Medicale Marzet | |
| Pau, France, 64000 | |
| Medipole Gentilly Saint-Jacques | |
| Maxeville, France, 54320 | |
| Polyclinique Bordeaux Nord Aquitaine | |
| Boucher, France, 33300 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Polyclinique de L'Ormeau | |
| Tarbes, France, 65000 | |
| Polyclinique Du Parc Centre Maurice Tubiana | |
| Caen, France, 14052 | |
| Clinique Clementville | |
| Montpellier, France | |
| Investigator: | Jean F. Morere, MD | Hopital Avicenne |
More Information
| Study ID Numbers: | CDR0000350015, FRE-GERCOR-B00-1, EU-20330 |
| Study First Received: | February 10, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077220 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Adjuvants, Immunologic Antimitotic Agents Carboplatin Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Paclitaxel Lung Neoplasms Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
