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
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
3 other identifiers
interventional
N/A
1 country
68
Brief Summary
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.
Trial Health
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68 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 10, 2004
CompletedFirst Posted
Study publicly available on registry
February 11, 2004
CompletedFebruary 9, 2009
May 1, 2007
February 10, 2004
February 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Secondary Outcomes (3)
Objective response rate
Overall survival
Toxicity
Interventions
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (68)
Centre Hospitalier d'Annecy
Annecy, 74011 Cedex, France
Institut Sainte Catherine
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
Jean F. Morere, MD
Hopital Avicenne
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 10, 2004
First Posted
February 11, 2004
Study Start
June 1, 2002
Last Updated
February 9, 2009
Record last verified: 2007-05