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
- Lung Cancer
- Registration Number
- NCT00077220
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Toxicity Objective response rate Overall survival
Trial Locations
- Locations (67)
Institut Sainte Catherine
🇫🇷Avignon, France
Centre Hospitalier Bayeux
🇫🇷Bayeux, France
Clinique Tivoli
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Boucher, France
C.H.G Laval
🇫🇷Laval, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Hopital Duffaut
🇫🇷Avignon, France
Centre Hospitalier Chaumont
🇫🇷Chaumont, France
Clinique des Cedres
🇫🇷Cornebarrieu, France
Hopital Jean Monnet
🇫🇷Epinal, France
Centre d'Oncologie et de Radiotherapie de Chaumont le Bois
🇫🇷Chaumont, France
Centre Eugene Marquis
🇫🇷Rennes, France
Hopital Tenon
🇫🇷Paris, France
Polyclinique De Courlancy
🇫🇷Reims, France
Clinique les Bleuets
🇫🇷Reims, France
Hopital Saint-Louis
🇫🇷Paris, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Polyclinique Saint - Roch
🇫🇷Montpellier, France
Clinique De Valdegour
🇫🇷Nimes, France
Groupe Medical St. Remy
🇫🇷Reims, France
Centre Hospitalier De Saint Dizier
🇫🇷Saint Dizier, France
C. H. De Saumur
🇫🇷Saumur, France
Polyclinique de L'Ormeau
🇫🇷Tarbes, France
Centre Hospitalier De Vernon
🇫🇷Vernon, France
Centre Hospitalier de la Cote Basque
🇫🇷Bayonne, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Hopital Avicenne
🇫🇷Bobigny, France
Centre Hospitalier D'Evreux
🇫🇷Evreux, France
Clinique Pasteur
🇫🇷Evreux, France
Clinique du Petit Colmouilins
🇫🇷Harfleur, France
Centre Mallet - Proux
🇫🇷Laval, France
Centre Jean Bernard
🇫🇷Le Mans, France
C. H. Du Mans
🇫🇷Le Mans, France
Hopital Robert Boulin
🇫🇷Libourne, France
Clinique de le Louviere
🇫🇷Lille, France
Clinique Chenieux
🇫🇷Limoges, France
Clinique du Pont de Chaume
🇫🇷Montauban, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Clinique Clementville
🇫🇷Montpellier, France
Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Maison Medicale Marzet
🇫🇷Pau, France
Clinique Saint - Pierre
🇫🇷Perpignan, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Clinique Saint Vincent
🇫🇷Saint Gregoire, France
Clinique de l'Orangerie
🇫🇷Strasbourg, France
Polyclinique Du Parc Centre Maurice Tubiana
🇫🇷Caen, France
Clinique du Cedre
🇫🇷Bois-Guillaume, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Centre Hospitalier Chateaudun
🇫🇷Chateaudun, France
Hopital Louis Pasteur
🇫🇷Comar, France
Centre d'Oncologie et de Radiotherapie du Parc
🇫🇷Dijon, France
Centre Hospitalier General
🇫🇷Le Mans, France
Centre Guillaume Le Conquerant
🇫🇷Le Havre, France
Medipole Gentilly Saint-Jacques
🇫🇷Maxeville, France
Centre Hospitalier Robert Bisson
🇫🇷Lisieux, France
C.H. Du Havre
🇫🇷Montivilliers, France
Centre D'Oncologie De Gentilly
🇫🇷Nancy, France
CHR D'Orleans - Hopital de la Source
🇫🇷Orleans, France
C.H.G. De Pau
🇫🇷Pau, France
Centre Frederic Joliot
🇫🇷Rouen, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Clinique de l'Union
🇫🇷Saint Jean, France
Centre du Rouget
🇫🇷Sarcelles, France
Centre Hospitalier de Saint - Brieuc
🇫🇷Saint-Brieuc, France
Centre Hospitalier Regional Metz Thionville
🇫🇷Thionville, France
Centre Hospitalier de Valenciennes
🇫🇷Valenciennes, France
Clinique Medico Chirurgicale Teissier Groupe
🇫🇷Valenciennes, France