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Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer Clinical research trials and Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer. Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer clinical trial. Participants frequently get the best healthcare available for their Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer
Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: Recruiting
Sponsor(s): GERCOR ,
Synopsis: 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 chemotherapy combined with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectablestage II or stage III non-small cell lung cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of paclitaxel and carboplatin combined with radiation therapy with or without adjuvant paclitaxel and carboplatin in treating patients who have unresectable stage II or stage III non-small cell lung cancer.
Details: OBJECTIVES: Primary - Compare the progression-free survival of patients with stage II or III unresectable non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy with or without adjuvant paclitaxel and carboplatin. Secondary - Compare the objective response rate in patients treated with these regimens. - Compare the overall survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. 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. - Arm I: Patients undergo routine follow-up. - Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a maximum of 3 courses. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/79 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Stage II or III disease - Not amenable to surgery - 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 - 18 to 79 Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 Hepatic - Bilirubin < 1.5 times upper limit of normal (ULN) Renal - Creatinine < 1.25 times ULN Cardiovascular - No unstable heart disease Pulmonary - No ventilation dysfunction that would preclude radiotherapy Other - No weight loss of 15% or more within the past 2 months - No uncontrolled infection - No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 6 months since prior neoadjuvant chemotherapy - No prior adjuvant chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy Surgery - Not specified Other - No other concurrent clinical trial participation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanMorere, , Hopital Avicenne
Centre Hospitalier Regional Metz Thionville *Recruiting*
Thionville, , 57126
France
Recruiting Alain Beraud 33-3-8255-8899
Clinique du Petit Colmouilins *Recruiting*
Harfleur, , 76700
France
Recruiting Jean Duhamel 33-2-3555-6910
Centre Rene Huguenin *Recruiting*
Saint Cloud, , 92211
France
Recruiting E.G.C. Brain 33-147-111-515
Clinique Clementville *Recruiting*
Montpellier, ,
France
Recruiting Robert Regal 33-04-6792-6155
Clinique du Pont de Chaume *Recruiting*
Montauban, , 82017
France
Recruiting Alain Redon 33-05-6368-3333
Clinique les Bleuets *Recruiting*
Reims, , 51100
France
Recruiting Tredaniel Picavet 33-3-26-06-81-81
Hopital Avicenne *Recruiting*
Bobigny, , 93009
France
Recruiting Jean Morere 33-1-48-955-032
Hopital Tenon *Recruiting*
Paris, , 75970
France
Recruiting Jean-Pierre Lotz 33-1-5601-6058
Clinique De Valdegour *Recruiting*
Nimes, , 30900
France
Recruiting Arnaud Boutte 33-4-6662-5800
Institut Sainte Catherine *Recruiting*
Avignon, , 84082
France
Recruiting Francois Reboul 33-90-27-61-61
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Claire Lemanski 33-04-6761-3134
Hopital Fontenoy *Recruiting*
Chartres, , 28018
France
Recruiting A. Salemkour 33-0-237303270
Hopital Robert Boulin *Recruiting*
Libourne, , 33500
France
Recruiting Bertrand Darpeix 33-5-5755-3434
Hopital Saint-Louis *Recruiting*
Paris, , 75475
France
Recruiting Christophe Hennequin 33-1-4249-4949
Polyclinique de L'Ormeau *Recruiting*
Tarbes, , 65000
France
Recruiting Bernard Couderc 33-056-293-5929
Polyclinique Saint - Roch *Recruiting*
Montpellier, , 34000
France
Recruiting Jean-Louis Baticle 33-4-9961-4000
Centre Hospitalier General *Recruiting*
Le Mans, , 72037
France
Recruiting F-Xavier Lebas 33-2-43-43-25-43
Centre d'Oncologie et de Radiotherapie du Parc *Recruiting*
Dijon, , 21000
France
Recruiting Thierry Altwegg 33-3-80-673-010
Clinique Saint - Pierre *Recruiting*
Perpignan, ,
France
Recruiting Daniel Castera 33-09-6839-0742
Polyclinique Bordeaux Nord Aquitaine *Recruiting*
Boucher, , 33300
France
Recruiting Francois Guichard 33-5-56-43-73-54
Centre Hospitalier Chateaudun *Recruiting*
Chateaudun, , 28200
France
Recruiting Rabut 33-02-3744-4040
Polyclinique De Courlancy *Recruiting*
Reims, , F-51100
France
Recruiting Philippe Colin 33-3-2684-0284
C.H.G. Beauvais *Recruiting*
Beauvais, , 60021
France
Recruiting J.L. Dutel 33-344-112-309
Centre D'Oncologie De Gentilly *Recruiting*
Nancy, , 54100
France
Recruiting Pierre Baumann 33-3-8393-5005
Centre Hospitalier de la Cote Basque *Recruiting*
Bayonne, , 64109
France
Recruiting Dominique Larregain-Tournier 33-05-5944-3535
Clinique du Cedre *Recruiting*
Bois-Guillaume, , 76230
France
Recruiting Labbe 33-02-3559-5959
Clinique Tivoli *Recruiting*
Bordeaux, , F-33030
France
Recruiting Patrick Bonichon 33-5-5611-6000
C.H.G Laval *Recruiting*
Laval, , 53024
France
Recruiting Jean Le Lain 33-02-4366-5000
Centre Hospitalier Chaumont *Recruiting*
Chaumont, , 52000
France
Recruiting Bernard Simon 33-03-2530-7030
C.H. Du Havre *Recruiting*
Montivilliers, , F-76290
France
Recruiting Marc Peureux 33-02-3273-3232
Centre Hospitalier de Saint - Brieuc *Recruiting*
Saint-Brieuc, , 22023
France
Recruiting Eric Briens 33-2-9601-7123
Centre Hospitalier de Valenciennes *Recruiting*
Valenciennes, ,
France
Recruiting Jean Roux 33-03-2714-2434
Clinique Armoricaine De Radiologie *Recruiting*
Saint Brieux, , F-22015
France
Recruiting Anne-Claire Hardy-Bessard 33-2-96-75-22-16
Clinique Chenieux *Recruiting*
Limoges, , 87000
France
Recruiting Jean-Jacques Pavy 33-05-5545-4040
Clinique des Cedres *Recruiting*
Cornebarrieu, , 31700
France
Recruiting Pierre Mourlalette 33-05-6213-3203
Hopital Jean Monnet *Recruiting*
Epinal, , BP590
France
Recruiting Collignon 33-3-2968-7000
Hopital Saint Andre *Recruiting*
Bordeaux, , 33075
France
Recruiting Renaud Trouette 33-05-795-808
Polyclinique Du Parc Centre Maurice Tubiana *Recruiting*
Caen, , 14052
France
Recruiting Patrick Allain 33-23-182-8282
Centre Eugene Marquis *Recruiting*
Rennes, , 35042
France
Recruiting Mohamed Hassel 33-2-99-25-3000
Centre Guillaume Le Conquerant *Recruiting*
Le Havre, , 76600
France
Recruiting Laurent Martin 33-2-3522-7161
Centre Hospitalier De Vernon *Recruiting*
Vernon, , 27200
France
Recruiting Nadege Gueteau 33-2-3271-6600
Centre Hospitalier D'Evreux *Recruiting*
Evreux, , 27000
France
Recruiting Jacques Bres 33-2-3233-8000
Centre Hospitalier Robert Bisson *Recruiting*
Lisieux, , 14100
France
Recruiting Driss Abouz 33-23-182-8282
Centre Mallet - Proux *Recruiting*
Laval, , 53000
France
Recruiting Daniel Martin 33-02-4364-1333
Clinique Medico Chirurgicale Teissier Groupe *Recruiting*
Valenciennes, ,
France
Recruiting Dufour 33-3-2714-2434
Clinique Pasteur *Recruiting*
Evreux, , 27000
France
Recruiting Daniel Lepille 33-02-3238-1202
Clinique Saint Vincent *Recruiting*
Saint-Gregoire, , 35700
France
Recruiting James Bassoulet 33-2-992-333-33
C. H. De Saumur *Recruiting*
Saumur, , 49403
France
Recruiting Michel Maigre 33-2-4153-3030
Centre Frederic Joliot *Recruiting*
Rouen, , 76000
France
Recruiting Philippe Gomez 33-2-3276-4076
Centre Hospitalier de Mulhouse *Recruiting*
Mulhouse, , 68051
France
Recruiting Anne-Marie Elgard 33-3-8964-6464
Oncologie Medicale *Recruiting*
Saint-Jean, , 31240
France
Recruiting Franck Burki 33-61-37-81-81
C. H. Du Mans *Recruiting*
Le Mans, , 72037
France
Recruiting Isabelle Simon 33-02-4343-4343
C.H.G. De Pau *Recruiting*
Pau, , 64000
France
Recruiting Marie Benichou 33-5-59-924-982
Centre Hospitalier Bayeux *Recruiting*
Bayeux, , 14400
France
Recruiting Jean-Paul Leterrier 33-02-3151-5151
Centre Hospitalier d'Annecy *Recruiting*
Annecy, , 74011 Cedex
France
Recruiting S. Hominal 33-04-5088-3341
Clinique de le Louviere *Recruiting*
Lille, , F-59800
France
Recruiting Francois Fortin 33-3-2016-0530
Hopital Duffaut *Recruiting*
Avignon, , 84902
France
Recruiting Alain Rabanit 33-04-3275-3333
Hopital Notre-Dame de Bon Secours *Recruiting*
Metz, , 55038
France
Recruiting Nadine Paillot 33-3-87-55-36-95
Medipole Gentilly Saint-Jacques *Recruiting*
Maxeville, , 54320
France
Recruiting Issartel 33-03-8393-5080
Centre d'Oncologie et de Radiotherapie de Chaumont le Bois *Recruiting*
Chaumont, , 52000
France
Recruiting Francois Bildstein 33-3-2532-3960
CHR D'Orleans - Hopital de la Source *Recruiting*
Orleans, , 45100
France
Recruiting Nadia Raban 33-02-3851-4444
Clinique de l'Orangerie *Recruiting*
Strasbourg, , 67010
France
Recruiting Jean-Philippe Wagner 33-3-8856-7300
Groupe Medical St. Remy *Recruiting*
Reims, , 51100
France
Recruiting Frederic Masure 33-03-2685-2006
Hopital Louis Pasteur *Recruiting*
Comar, , 68021
France
Recruiting Jean Poster 33-03-8912-4000
Centre du Rouget *Recruiting*
Sarcelles, , 95250
France
Recruiting Aime-Andre Kanoui 33-13-990-4955
Centre Hospitalier De Saint Dizier *Recruiting*
Saint-Dizier, , 52100
France
Recruiting Billon 33-3-2556-8484
Centre Jean Bernard *Recruiting*
Le Mans, , 72000
France
Recruiting Gerard Ganem 33-2-4324-1266
Maison Medicale Marzet *Recruiting*
Pau, , 64000
France
Recruiting Jean-Pierre Dujol 33-5-5992-7272
Additional Information:
Study ID Numbers: CDR0000350015; FRE-GERCOR-B00-1,EU-20330
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077220
Other Stage 2 Non-Small Cell Lung Cancer Studies:
1. Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer
2. Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
4. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
5. Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
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Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer
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