Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
Concurrent Carboplatin, Paclitaxel, and Radiation Therapy Versus Induction Carboplatin and Paclitaxel Followed by Concurrent Carboplatin, Paclitaxel and Radiation Therapy for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase III Trial
RATIONALE: Drugs used in chemotherapy use 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 before combined chemotherapy and radiation therapy is more effective than combined chemotherapy and radiation therapy alone in treating patients with non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed during surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES: I. Compare the effects of concurrent chemoradiotherapy utilizing carboplatin and paclitaxel with or without prior induction chemotherapy on overall response rate, disease-free survival, and overall survival in patients with unresectable stage III non-small cell lung cancer. II. Compare the effects of these treatments on locoregional vs distant failure in these patients. III. Compare the toxicity of these treatments in these patients.
OUTLINE: This is a randomized study. Patients are stratified by measurable vs evaluable disease. Patients are randomized to 1 of 2 treatment arms: Arm I (immediate concurrent chemoradiotherapy): Patients receive IV paclitaxel over 1 hour followed by IV carboplatin over 30 minutes on day 1, and radiation therapy to the chest 5 times a week beginning on day 1. Treatment repeats weekly for a total of 7 courses. Arm II (induction chemotherapy followed by delayed concurrent chemoradiotherapy): Patients receive IV paclitaxel over 3 hours followed by IV carboplatin over 30 minutes; treatment repeats every 3 weeks for 2 courses. Patients then receive 7 courses of concurrent chemoradiotherapy as in Arm I. Total treatment time is 13 weeks. Patients are followed every 2 months for 2 years, then every 4 months for the next 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 3 years.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35233-1996
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, États-Unis, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, États-Unis, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, États-Unis, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, États-Unis, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, États-Unis, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, États-Unis, 20060
- Howard University Cancer Center
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Florida
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Miami Beach, Florida, États-Unis, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, États-Unis, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, États-Unis, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, États-Unis, 60612
- University of Illinois at Chicago Health Sciences Center
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Iowa
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Bettendorf, Iowa, États-Unis, 52722
- Hematology Oncology Associates of the Quad Cities
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Iowa City, Iowa, États-Unis, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maine
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Togus, Maine, États-Unis, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, États-Unis, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55417
- Veterans Affairs Medical Center - Minneapolis
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Missouri
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Columbia, Missouri, États-Unis, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, États-Unis, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, États-Unis, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, États-Unis, 68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, États-Unis, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756-0002
- Norris Cotton Cancer Center
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New Jersey
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Camden, New Jersey, États-Unis, 08103
- Cooper Cancer Institute
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New York
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Buffalo, New York, États-Unis, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, États-Unis, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, États-Unis, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, États-Unis, 11030
- North Shore University Hospital
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New York, New York, États-Unis, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, États-Unis, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, États-Unis, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, États-Unis, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, États-Unis, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, États-Unis, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, États-Unis, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, États-Unis, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, États-Unis, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, États-Unis, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, États-Unis, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, États-Unis, 38103
- University of Tennessee, Memphis Cancer Center
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Memphis, Tennessee, États-Unis, 38104
- Veterans Affairs Medical Center - Memphis
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Vermont
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White River Junction, Vermont, États-Unis, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, États-Unis, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, États-Unis, 23249
- Veterans Affairs Medical Center - Richmond
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Inoperable or unresectable stage IIIA or IIIB disease of the following stage groupings: T1 N2 M0 or T2 N2 M0 T3 N2 M0 and T4 N0-2 M0 eligible if staging is based on closeness to the carina or invasion of the mediastinum or chest wall Patients with contralateral mediastinal disease (N3) or tumors adjacent to but not invading a vertebral body are eligible if all gross disease can be encompassed in the study radiation boost field Patients with a transudate, cytologically negative, nonbloody pleural effusion are eligible if the tumor can be encompassed within a reasonable field of radiotherapy Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALBG 0-1 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 2 times upper limit of normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant or nursing Effective contraception required of fertile patients No active second malignancy except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormones except for steroids administered for adrenal failure or septic shock, or hormones administered for non-disease-related conditions (e.g., insulin for diabetes) Glucocorticosteroids permitted as antiemetics Radiotherapy: No prior radiotherapy Surgery: At least 2 weeks since exploratory thoracotomy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Chemo + radiation
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Expérimental: Induction chemo + chemo & radiation
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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la survie globale
Délai: Jusqu'à 5 ans
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Jusqu'à 5 ans
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taux de réponse global
Délai: Jusqu'à 5 ans
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Jusqu'à 5 ans
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survie sans maladie
Délai: Jusqu'à 5 ans
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Jusqu'à 5 ans
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Everett E. Vokes, MD, University of Chicago
Publications et liens utiles
Publications générales
- Stinchcombe TE, Hodgson L, Herndon JE 2nd, Kelley MJ, Cicchetti MG, Ramnath N, Niell HB, Atkins JN, Akerley W, Green MR, Vokes EE; Cancer and Leukemia Group B. Treatment outcomes of different prognostic groups of patients on cancer and leukemia group B trial 39801: induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for unresectable stage III non-small cell lung cancer. J Thorac Oncol. 2009 Sep;4(9):1117-25. doi: 10.1097/JTO.0b013e3181b27b33.
- Vokes EE, Herndon JE 2nd, Kelley MJ, Cicchetti MG, Ramnath N, Neill H, Atkins JN, Watson DM, Akerley W, Green MR; Cancer and Leukemia Group B. Induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for regionally advanced unresectable stage III Non-small-cell lung cancer: Cancer and Leukemia Group B. J Clin Oncol. 2007 May 1;25(13):1698-704. doi: 10.1200/JCO.2006.07.3569. Epub 2007 Apr 2.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Carboplatine
- Paclitaxel
Autres numéros d'identification d'étude
- CALGB-39801
- U10CA031946 (Subvention/contrat des NIH des États-Unis)
- CLB-39801
- CDR0000066383 (Identificateur de registre: NCI Physician Data Query)
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