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S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma

20 de marzo de 2020 actualizado por: Southwest Oncology Group

A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab.

Secondary

  • Determine the progression-free survival of patients treated with this regimen.
  • Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed by a central computer-assisted image-analysis system in patients with measurable disease treated with this regimen.
  • Assess the frequency and severity of toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

84

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Antioch, California, Estados Unidos, 94531
        • Kaiser Permanente - Deer Valley
      • Berkeley, California, Estados Unidos, 94704
        • Alta Bates Summit Comprehensive Cancer Center
      • Burlingame, California, Estados Unidos, 94010
        • Peninsula Medical Center
      • Fremont, California, Estados Unidos, 94538
        • Kaiser Permanente - Fremont
      • Hayward, California, Estados Unidos, 94545
        • Kaiser Permanente Medical Center - Hayward
      • Marysville, California, Estados Unidos, 95901
        • Tibotec Therapeutics - Division of Ortho Biotech Products, LP
      • Oakland, California, Estados Unidos, 94611
        • Kaiser Permanente Medical Center - Oakland
      • Pleasanton, California, Estados Unidos, 94588
        • Valley Medical Oncology Consultants - Pleasanton
      • Redwood City, California, Estados Unidos, 94063
        • Kaiser Permanente Medical Center - Redwood City
      • Richmond, California, Estados Unidos, 94801
        • Kaiser Permanente Medical Center - Richmond
      • Roseville, California, Estados Unidos, 95661
        • Kaiser Permanente Medical Center - Roseville
      • Sacramento, California, Estados Unidos, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, Estados Unidos, 95823
        • South Sacramento Kaiser-Permanente Medical Center
      • Sacramento, California, Estados Unidos, 95825
        • Kaiser Permanente Medical Center - Sacramento
      • San Francisco, California, Estados Unidos, 94115
        • Kaiser Permanente Medical Center - San Francisco Geary Campus
      • San Francisco, California, Estados Unidos, 94118
        • California Pacific Medical Center - California Campus
      • San Jose, California, Estados Unidos, 95119
        • Kaiser Permanente Medical Center - Santa Teresa
      • San Rafael, California, Estados Unidos, 94903
        • Sutter Health - Western Division Cancer Research Group
      • San Rafael, California, Estados Unidos, 94903
        • Kaiser Foundation Hospital - San Rafael
      • Santa Clara, California, Estados Unidos, 95051
        • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
      • Santa Rosa, California, Estados Unidos, 95403
        • Kaiser Permanente Medical Center - Santa Rosa
      • South San Francisco, California, Estados Unidos, 94080
        • Kaiser Permanente Medical Center - South San Francisco
      • Stockton, California, Estados Unidos, 95210
        • Kaiser Permanente Medical Facility - Stockton
      • Truckee, California, Estados Unidos, 96161
        • Tahoe Forest Cancer Center
      • Vacaville, California, Estados Unidos, 95688
        • Kaiser Permanente Medical Center - Vacaville
      • Vallejo, California, Estados Unidos, 94589
        • Sutter Solano Medical Center
      • Vallejo, California, Estados Unidos, 94589
        • Kaiser Permanente Medical Center - Vallejo
      • Walnut Creek, California, Estados Unidos, 94596
        • Kaiser Permanente Medical Center - Walnut Creek
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, Estados Unidos, 30342-1611
        • Northside Hospital Cancer Center
      • Atlanta, Georgia, Estados Unidos, 30342-1701
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, Estados Unidos, 30342
        • CCOP - Atlanta Regional
      • Austell, Georgia, Estados Unidos, 30106
        • WellStar Cobb Hospital
      • Columbus, Georgia, Estados Unidos, 31904
        • John B. Amos Cancer Center
      • Decatur, Georgia, Estados Unidos, 30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Fayetteville, Georgia, Estados Unidos, 30214
        • Piedmont Fayette Hospital
      • Gainesville, Georgia, Estados Unidos, 30501
        • Northeast Georgia Medical Center
      • Lawrenceville, Georgia, Estados Unidos, 30045
        • Gwinnett Medical Center
      • Marietta, Georgia, Estados Unidos, 30060
        • Kennestone Cancer Center at Wellstar Kennestone Hospital
      • Riverdale, Georgia, Estados Unidos, 30274-2600
        • Southern Regional Medical Center
      • Rome, Georgia, Estados Unidos, 30165
        • Harbin Clinic Cancer Center - Medical Oncology
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96819
        • Kaiser Permanente - Moanalua Medical Center and Clinic
    • Illinois
      • Decatur, Illinois, Estados Unidos, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Maywood, Illinois, Estados Unidos, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Springfield, Illinois, Estados Unidos, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Kansas
      • Chanute, Kansas, Estados Unidos, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Estados Unidos, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Estados Unidos, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Estados Unidos, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Estados Unidos, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Estados Unidos, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Estados Unidos, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Estados Unidos, 67901
        • Cancer Center of Kansas, PA - Liberal
      • Newton, Kansas, Estados Unidos, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Estados Unidos, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Estados Unidos, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Estados Unidos, 67401
        • Cancer Center of Kansas, PA - Salina
      • Salina, Kansas, Estados Unidos, 67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
      • Topeka, Kansas, Estados Unidos, 66606
        • Cotton-O'Neil Cancer Center
      • Wellington, Kansas, Estados Unidos, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Estados Unidos, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Estados Unidos, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Estados Unidos, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Estados Unidos, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Estados Unidos, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Estados Unidos, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, Estados Unidos, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, Estados Unidos, 49307
        • Mecosta County Medical Center
      • Dearborn, Michigan, Estados Unidos, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Flint, Michigan, Estados Unidos, 48503
        • Hurley Medical Center
      • Flint, Michigan, Estados Unidos, 48503
        • Genesys Hurley Cancer Institute
      • Grand Blanc, Michigan, Estados Unidos, 48439
        • Genesys Regional Medical Center
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, Estados Unidos, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Jackson, Michigan, Estados Unidos, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, Estados Unidos, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Estados Unidos, 48154
        • St. Mary Mercy Hospital
      • Muskegon, Michigan, Estados Unidos, 49443
        • Mercy General Health Partners
      • Pontiac, Michigan, Estados Unidos, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Estados Unidos, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, Estados Unidos, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Traverse City, Michigan, Estados Unidos, 49684
        • Munson Medical Center
      • Warren, Michigan, Estados Unidos, 48093
        • St. John Macomb Hospital
      • Wyoming, Michigan, Estados Unidos, 49519
        • Metro Health Hospital
    • Montana
      • Billings, Montana, Estados Unidos, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Estados Unidos, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Estados Unidos, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, Estados Unidos, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, Estados Unidos, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Estados Unidos, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Estados Unidos, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, Estados Unidos, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, Estados Unidos, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Havre, Montana, Estados Unidos, 59501
        • Northern Montana Hospital
      • Helena, Montana, Estados Unidos, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Estados Unidos, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Estados Unidos, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, Estados Unidos, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, Estados Unidos, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Estados Unidos, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • North Carolina
      • Goldsboro, North Carolina, Estados Unidos, 27534
        • Wayne Memorial Hospital, Incorporated
      • Hendersonville, North Carolina, Estados Unidos, 28791
        • Pardee Memorial Hospital
    • Ohio
      • Bellefontaine, Ohio, Estados Unidos, 43311
        • Mary Rutan Hospital
      • Chillicothe, Ohio, Estados Unidos, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, Estados Unidos, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Estados Unidos, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, Estados Unidos, 43215
        • CCOP - Columbus
      • Columbus, Ohio, Estados Unidos, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, Estados Unidos, 43228
        • Doctors Hospital at Ohio Health
      • Delaware, Ohio, Estados Unidos, 43015
        • Grady Memorial Hospital
      • Lancaster, Ohio, Estados Unidos, 43130
        • Fairfield Medical Center
      • Marietta, Ohio, Estados Unidos, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Mount Vernon, Ohio, Estados Unidos, 43050
        • Knox Community Hospital
      • Newark, Ohio, Estados Unidos, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Springfield, Ohio, Estados Unidos, 45505
        • Community Hospital of Springfield and Clark County
      • Westerville, Ohio, Estados Unidos, 43081
        • Mount Carmel St. Ann's Cancer Center
      • Zanesville, Ohio, Estados Unidos, 43701
        • Genesis - Good Samaritan Hospital
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Utah
      • American Fork, Utah, Estados Unidos, 84003
        • American Fork Hospital
      • Cedar City, Utah, Estados Unidos, 84720
        • Sandra L. Maxwell Cancer Center
      • Logan, Utah, Estados Unidos, 84321
        • Logan Regional Hospital
      • Murray, Utah, Estados Unidos, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, Estados Unidos, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, Estados Unidos, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Estados Unidos, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Estados Unidos, 84143
        • LDS Hospital
      • Salt Lake City, Utah, Estados Unidos, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Washington
      • Bellingham, Washington, Estados Unidos, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, Estados Unidos, 98310
        • Olympic Hematology and Oncology
      • Kennewick, Washington, Estados Unidos, 99336
        • Columbia Basin Hematology
      • Mount Vernon, Washington, Estados Unidos, 98274
        • Skagit Valley Hospital Cancer Care Center
      • Poulsbo, Washington, Estados Unidos, 98370
        • Harrison Poulsbo Hematology and Onocology
      • Seattle, Washington, Estados Unidos, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Estados Unidos, 98104
        • Harborview Medical Center
      • Seattle, Washington, Estados Unidos, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, Estados Unidos, 98112
        • Group Health Central Hospital
      • Seattle, Washington, Estados Unidos, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Estados Unidos, 98195
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, Estados Unidos, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, Estados Unidos, 99218
        • Evergreen Hematology and Oncology, PS
      • Wenatchee, Washington, Estados Unidos, 98801-2028
        • Wenatchee Valley Medical Center
    • Wyoming
      • Sheridan, Wyoming, Estados Unidos, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 120 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

DISEASE CHARACTERISTICS:

  • Biopsy-proven* bronchioloalveolar carcinoma (BAC) or BAC variants (e.g., adenocarcinoma with BAC features, BAC with invasive adenocarcinoma) meeting the following criteria:

    • Incompletely resected or unresectable disease
    • No component of squamous cell carcinoma

    • Disease staged as 1 of the following:

      • Stage IIIB disease (T4 [cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor], any N, M0)

      • Stage IV disease (any T, any N, M1 [distant metastases present])

        • Recurrent disease in a separate lobe after prior resection within the past 5 years; multifocal lesions in > 1 lobe; or any disease that is recurrent after surgery or radiotherapy is considered stage IV disease
    • Tumor may be multifocal or diffuse NOTE: *Cytology specimens, including bronchial brushing, washings, or fine needle aspiration specimens, alone are not acceptable for diagnosis

  • Measurable or nonmeasurable disease by chest CT scan

    • Pleural effusions, ascites, and laboratory parameters are not acceptable as only evidence of disease
    • Disease must be present outside field of prior radiotherapy OR a new lesion must be inside port
  • Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin normal
  • AST or AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases are present)
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
  • Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1 g by 24-hour urine collection
  • Willing to provide prior smoking history
  • No hemoptysis ≥ ½ teaspoon within the past 28 days
  • No clinical history of pulmonary or upper respiratory hemorrhage > grade 2 within the past 6 months or > grade 1 within the past 28 days
  • No history of thromboses or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding
  • No uncontrolled hypertension
  • No serious nonhealing wound, ulcer, or bone fracture

  • No other prior malignancy except for any of the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Adequately treated stage I or II cancer that is currently in complete remission
    • Any other cancer from which the patient has been disease free for 5 years
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 28 days since prior radiotherapy (14 days for palliative radiotherapy)
  • At least 28 days since prior surgery (thoracic or other major surgeries)
  • More than 7 days since prior fine-needle aspiration or core biopsy
  • At least 28 days since prior systemic chemotherapy or biologic therapy
  • No prior gefitinib hydrochloride, erlotinib hydrochloride, or bevacizumab
  • No other prior anti-epidermal growth factor receptor or anti-vascular endothelial growth factor therapies
  • Concurrent stable, therapeutic anticoagulation therapy allowed (i.e., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation
  • No other concurrent anticancer therapy, including surgery, chemotherapy, hormone therapy, biologic therapy, or radiotherapy

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Erlotinib and Bevacizumab
Biológico: bevacizumab
Droga: clorhidrato de erlotinib

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Overall Survival
Periodo de tiempo: From date of registration to maximum of 3 years
From date of registration to maximum of 3 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival
Periodo de tiempo: From date of registration to maximum of 3 years
From date of registration to maximum of 3 years
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease
Periodo de tiempo: From date of registration to maximum of 3 years
Images for response assessed by the central computer-assisted image-analysis system were never collected.
From date of registration to maximum of 3 years
Frequency and Severity of Toxicities
Periodo de tiempo: From date of registration to maximum of 3 years
From date of registration to maximum of 3 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Southwest Oncology Group

Colaboradores

National Cancer Institute (NCI)

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • West HJ, Moon J, Hirsch FR, et al.: SWOG S0635 and S0636: Phase II trials in advanced-stage NSCLC of erlotinib (OSI-774) and bevacizumab in bronchioloalveolar carcinoma (BAC) and adenocarcinoma with BAC features (adenoBAC), and in never-smokers with primary NSCLC adenocarcinoma (adenoCa). [Abstract] J Clin Oncol 30 (Suppl 15): A-7517, 2012.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2007

Finalización primaria (Actual)

20 de julio de 2019

Finalización del estudio (Actual)

20 de agosto de 2019

Fechas de registro del estudio

Enviado por primera vez

15 de febrero de 2007

Primero enviado que cumplió con los criterios de control de calidad

15 de febrero de 2007

Publicado por primera vez (Estimar)

19 de febrero de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de abril de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

20 de marzo de 2020

Última verificación

1 de marzo de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000529756
  • U10CA032102 (Subvención/contrato del NIH de EE. UU.)
  • S0635 (Otro identificador: SWOG)

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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