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
NCT ID: NCT00077220
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
2002-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
paclitaxel
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
79 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
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Jean F. Morere, MD
Role:
Hopital Avicenne
Locations
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Centre Hospitalier d'Annecy
Annecy, , France
Institut Sainte Catherine
Avignon, , France
Hopital Duffaut
Avignon, , France
Centre Hospitalier Bayeux
Bayeux, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
C.H.G. Beauvais
Beauvais, , France
Hopital Avicenne
Bobigny, , France
Clinique du Cedre
Bois-Guillaume, , France
Hopital Saint Andre
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Boucher, , France
Polyclinique Du Parc Centre Maurice Tubiana
Caen, , France
Hopital Louis Pasteur
Chartres, , France
Centre d'Oncologie et de Radiotherapie de Chaumont le Bois
Chaumont, , France
Centre Hospitalier Chaumont
Chaumont, , France
Centre Hospitalier Chateaudun
Châteaudun, , France
Hopital Louis Pasteur
Comar, , France
Clinique des Cedres
Cornebarrieu, , France
Centre d'Oncologie et de Radiotherapie du Parc
Dijon, , France
Hopital Jean Monnet
Épinal, , France
Centre Hospitalier D'Evreux
Évreux, , France
Clinique Pasteur
Évreux, , France
Clinique du Petit Colmouilins
Harfleur, , France
Centre Mallet - Proux
Laval, , France
C.H.G Laval
Laval, , France
Centre Guillaume Le Conquerant
Le Havre, , France
Centre Jean Bernard
Le Mans, , France
C. H. Du Mans
Le Mans, , France
Centre Hospitalier General
Le Mans, , France
Hopital Robert Boulin
Libourne, , France
Clinique de le Louviere
Lille, , France
Clinique Chenieux
Limoges, , France
Centre Hospitalier Robert Bisson
Lisieux, , France
Medipole Gentilly Saint-Jacques
Maxéville, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Clinique du Pont de Chaume
Montauban, , France
C.H. Du Havre
Montivilliers, , France
Polyclinique Saint - Roch
Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Clinique Clementville
Montpellier, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Centre D'Oncologie De Gentilly
Nancy, , France
Clinique De Valdegour
Nîmes, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Hopital Saint-Louis
Paris, , France
Hopital Tenon
Paris, , France
C.H.G. De Pau
Pau, , France
Maison Medicale Marzet
Pau, , France
Clinique Saint - Pierre
Perpignan, , France
Clinique les Bleuets
Reims, , France
Groupe Medical St. Remy
Reims, , France
Polyclinique De Courlancy
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Frederic Joliot
Rouen, , France
Centre Hospitalier de Saint - Brieuc
Saint-Brieuc, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Centre Hospitalier De Saint Dizier
Saint-Dizier, , France
Clinique Saint Vincent
Saint-Grégoire, , France
Clinique de l'Union
Saint-Jean, , France
Centre du Rouget
Sarcelles, , France
C. H. De Saumur
Saumur, , France
Clinique de l'Orangerie
Strasbourg, , France
Polyclinique de L'Ormeau
Tarbes, , France
Centre Hospitalier Regional Metz Thionville
Thionville, , France
Centre Hospitalier de Valenciennes
Valenciennes, , France
Clinique Medico Chirurgicale Teissier Groupe
Valenciennes, , France
Centre Hospitalier De Vernon
Vernon, , France
Countries
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Other Identifiers
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FRE-GERCOR-B00-1
Identifier Type: -
Identifier Source: secondary_id
EU-20330
Identifier Type: -
Identifier Source: secondary_id
CDR0000350015
Identifier Type: -
Identifier Source: org_study_id
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