- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00033553
Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Induction/Concurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients With Stage III Non Small Cell Lung Cancer: A Randomized Phase II Study
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. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Compare the overall response rate, failure-free survival, and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-D XRT) vs gemcitabine and carboplatin with concurrent 3-D XRT.
- Compare the toxicity of these regimens in these patients.
- Compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens.
- Determine the feasibility of delivering 3-D XRT to patients in this multicenter study.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-D XRT) once daily 5 days a week. Treatment repeats weekly for 7 courses.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I. Treatment repeats weekly for 7 courses.
In both arms, treatment continues in the absence of disease progression.
Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 82 patients (41 per treatment arm) will be accrued for this study within 9 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Anniston, Alabama, Estados Unidos, 36207
- Northeast Alabama Regional Medical Center
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California
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La Jolla, California, Estados Unidos, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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San Diego, California, Estados Unidos, 92161
- Veterans Affairs Medical Center - San Diego
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San Diego, California, Estados Unidos, 92134-3202
- Naval Medical Center - San Diego
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San Francisco, California, Estados Unidos, 94115
- UCSF Comprehensive Cancer Center
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San Francisco, California, Estados Unidos, 94121
- Veterans Affairs Medical Center - San Francisco
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20422
- Veterans Affairs Medical Center - Washington, DC
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Washington, District of Columbia, Estados Unidos, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Estados Unidos, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center
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Hollywood, Florida, Estados Unidos, 33021
- Memorial Regional Cancer Center at Memorial Regional Hospital
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Miami Beach, Florida, Estados Unidos, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Estados Unidos, 32804
- Florida Hospital Cancer Institute
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60640
- Louis A. Weiss Memorial Hospital
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Peoria, Illinois, Estados Unidos, 61615-7828
- CCOP - Illinois Oncology Research Association
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River Forest, Illinois, Estados Unidos, 60305
- West Suburban Center for Cancer Care
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
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South Bend, Indiana, Estados Unidos, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Baptist Hospital East - Louisville
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester, Massachusetts, Estados Unidos, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Saint Joseph, Michigan, Estados Unidos, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Estados Unidos, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Estados Unidos, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198-7680
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, Estados Unidos, 89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Hooksett, New Hampshire, Estados Unidos, 03106
- New Hampshire Oncology-Hematology, PA - Hooksett
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Cancer Institute of New Jersey at the Cooper University Hospital
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New York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Estados Unidos, 14215
- Veterans Affairs Medical Center - Buffalo
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East Syracuse, New York, Estados Unidos, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Elmhurst, New York, Estados Unidos, 11373
- Elmhurst Hospital Center
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Jamaica, New York, Estados Unidos, 11432
- Queens Cancer Center of Queens Hospital
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Manhasset, New York, Estados Unidos, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Estados Unidos, 11030
- North Shore University Hospital
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center
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Syracuse, New York, Estados Unidos, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28805
- Veterans Affairs Medical Center - Asheville
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Concord, North Carolina, Estados Unidos, 28025
- NorthEast Oncology Associates - Concord
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Durham, North Carolina, Estados Unidos, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Fayetteville, North Carolina, Estados Unidos, 28302-2000
- Cape Fear Valley Health System
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Goldsboro, North Carolina, Estados Unidos, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Kinston, North Carolina, Estados Unidos, 28503-1678
- Lenoir Memorial Cancer Center
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Pinehurst, North Carolina, Estados Unidos, 28374
- Comprehensive Cancer Center at Moore Regional Hospital
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Wilmington, North Carolina, Estados Unidos, 28402-9025
- Zimmer Cancer Center at New Hanover Regional Medical Center
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Winston-Salem, North Carolina, Estados Unidos, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, Estados Unidos, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Western Pennsylvania Hospital
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02906
- Lifespan: The Miriam Hospital
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Texas
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Dallas, Texas, Estados Unidos, 75219
- Veterans Affairs Medical Center - Dallas
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Vermont
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Burlington, Vermont, Estados Unidos, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22902
- Martha Jefferson Hospital
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Norfolk, Virginia, Estados Unidos, 23502
- Virginia Oncology Associates - Norfolk
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Richmond, Virginia, Estados Unidos, 23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke, Virginia, Estados Unidos, 24014
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
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West Virginia
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Huntington, West Virginia, Estados Unidos, 25701
- St. Mary's Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Adenocarcinoma, including bronchoalveolar cell carcinoma
- Large cell anaplastic carcinoma, including giant and clear cell carcinoma
- Inoperable stage IIIA or IIIB disease
No direct invasion of vertebral body
- Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field
- Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field
- No scalene, supraclavicular, or contralateral hilar node involvement
Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field
- No exudative, bloody, or cytologically malignant pleural effusion
- Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions in a previously irradiated field
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
Renal:
- Creatinine clearance 20-130 mL/min for females
- Creatinine clearance 20-150 mL/min for males
Pulmonary:
- FEV1 at least 1.2 L
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for NSCLC
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for NSCLC
Surgery:
- At least 2 weeks since prior exploratory thoracotomy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Paclitaxel + Carboplatin
Paclitaxel and carboplatin induction (2 cycles)followed by chemotherapy with the addition of radiotherapy for 7 cycles
|
Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
225 mg/sq m IV over 3 hrs q 21 days for 2 cycles, then 45 mg/sq m IV over 1 hr q wk for 7 wks
3-D XRT 7400 cGy total after induction (during cycles 3-9)
|
Experimental: Gemcitabine + Carboplatin
Gemcitabine and carboplatin induction (2cycles) followed by chemotherapy with the addition of radiotherapy for 7 cycles
|
Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
3-D XRT 7400 cGy total after induction (during cycles 3-9)
1000 mg/sq m IV over 30 min days 1 & 8 repeat q 21 days for 2 cycles; then 35 mg/sq m IV over 30 min 2X wk for 7 wks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Response
Periodo de tiempo: 18 months post treatment
|
Response is assessed as failure free survival
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18 months post treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall Survival
Periodo de tiempo: 6 years post treatment
|
6 years post treatment
|
|
Toxicity
Periodo de tiempo: 13 weeks
|
Toxicity will be assessed during treatment
|
13 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Arthur William Blackstock, MD, Wake Forest University Health Sciences
Publicaciones y enlaces útiles
Publicaciones Generales
- Socinski MA, Blackstock AW, Bogart JA, Wang X, Munley M, Rosenman J, Gu L, Masters GA, Ungaro P, Sleeper A, Green M, Miller AA, Vokes EE. Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105. J Clin Oncol. 2008 May 20;26(15):2457-63. doi: 10.1200/JCO.2007.14.7371.
- Blackstock AW, Socinski MA, Bogart J, et al.: Induction (Ind) plus concurrent (Con) chemotherapy with high-dose (74 Gy) 3-dimensional (3-D) thoracic radiotherapy (TRT) in stage III non-small cell lung cancer (NSCLC): preliminary report of Cancer and Leukemia Group B (CALGB) 30105. [Abstract] J Clin Oncol 24 (Suppl 18): A-7042, 374s, 2006.
- Blackstock AW, Socinski MA, Gu L, et al.: Initial pulmonary toxicity evaluation of chemoradiotherapy (CRT) utilizing 74 Gy 3-dimensional (3-D) thoracic radiation in stage III non-small cell lung cancer (NSCLC): a Cancer and Leukemia Group B (CALGB) randomized phase II trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-7060, 635s, 2005.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Gemcitabina
- Carboplatino
- Paclitaxel
Otros números de identificación del estudio
- CALGB-30105
- U10CA031946 (Subvención/contrato del NIH de EE. UU.)
- CDR0000069300 (Identificador de registro: NCI Physician Data Query)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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