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Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

4 de octubre de 2019 actualizado por: Alliance for Clinical Trials in Oncology

A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients With Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller

This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVES:

I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local recurrence includes recurrence within the same lobe or hilum [N1 nodes], or progression at the staple line after treatment effects such as scarring have subsided).

SECONDARY OBJECTIVES:

I. To compare procedure specific morbidity and mortality between study arms. II. To compare overall survival and failure-free survival between study arms. III. To assess freedom from regional or distant recurrence. IV. To assess the effect of histological or cytologic positive resection margins on time to local recurrence.

V. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the effect of brachytherapy on pulmonary function.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.

ARM II: Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin.

After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36 months and then yearly for 2 years.

Tipo de estudio

Intervencionista

Inscripción (Actual)

224

Fase

  • Fase 3

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

  • Canadá
    • Ontario
      • London, Ontario, Canadá, N6A 4L6
        • London Regional Cancer Program at London Health Sciences Centre
  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259-5499
        • Mayo Clinic Scottsdale
    • California
      • Sacramento, California, Estados Unidos, 95817
        • University of California Davis Cancer Center
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Mayo Clinic - Jacksonville
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Winship Cancer Institute of Emory University
    • Illinois
      • Evanston, Illinois, Estados Unidos, 60201-1781
        • Evanston Hospital
      • Springfield, Illinois, Estados Unidos, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
      • Springfield, Illinois, Estados Unidos, 62794-9677
        • Simmons Cooper Cancer Institute
      • Springfield, Illinois, Estados Unidos, 62702
        • Cancer Institute at St. John's Hospital
    • Maryland
      • Towson, Maryland, Estados Unidos, 21204
        • Cancer Institute at St. Joseph Medical Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02118
        • Boston University Cancer Research Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109-0942
        • University of Michigan Comprehensive Cancer Center
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Ridgewood, New Jersey, Estados Unidos, 07450
        • Valley Hospital - Ridgewood
    • New York
      • Oceanside, New York, Estados Unidos, 11572
        • South Nassau Communities Hospital
      • Rochester, New York, Estados Unidos, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Syracuse, New York, Estados Unidos, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45267
        • Charles M. Barrett Cancer Center at University Hospital
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239-3098
        • Knight Cancer Institute At Oregon Health and Science University
    • Pennsylvania
      • New Castle, Pennsylvania, Estados Unidos, 16105
        • Jameson Memorial Hospital - North Campus
      • Philadelphia, Pennsylvania, Estados Unidos, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • UPMC Cancer Centers
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
      • Reading, Pennsylvania, Estados Unidos, 19612-6052
        • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02906
        • Miriam Hospital
      • Providence, Rhode Island, Estados Unidos, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37920-6999
        • U.T. Medical Center Cancer Institute
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Methodist Hospital
    • Utah
      • Murray, Utah, Estados Unidos, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • University of Virginia Cancer Center
    • Washington
      • Seattle, Washington, Estados Unidos, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Estados Unidos, 98111
        • Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION)
  • Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC)
  • Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
  • Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2

  • Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:

    • Major criteria

      • Forced expiratory volume in 1 second (FEV1) =< 50% predicted
      • Diffusing capacity of the lungs for carbon monoxide (DLCO) =< 50% predicted

    • Minor criteria

      • Age >= 75
      • FEV1 51-60% predicted
      • DLCO 51-60% predicted
      • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
      • Poor left ventricular function (defined as an ejection fraction of 40% or less)
      • Resting or exercise partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%
      • Partial pressure of carbon dioxide (pCO2) > 45 mm Hg
      • Modified Medical Research Council (MMRC) Dyspnea Scale >= 3
  • Patient must not have had previous intra-thoracic radiation therapy
  • Women of child-bearing potential must have negative serum or urine pregnancy test
  • No prior invasive malignancy, unless disease-free for >= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers)
  • PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION)
  • Patient must have biopsy-proven NSCLC
  • Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on positron emission tomography [PET] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Arm I
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Procedimiento: cirugía
Experimental: Arm II
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Procedimiento: cirugía
Radiación: braquiterapia

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Local Recurrence
Periodo de tiempo: Up to 3 years
Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.
Up to 3 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: Up to 5 years
OS was defined as the time from randomization to death due to any cause.
Up to 5 years
Number of Participants Reported Local Recurrence at 3 Years
Periodo de tiempo: 3 years
Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.
3 years
Number of Participants Reported Regional Recurrence at 3 Years
Periodo de tiempo: 3 years
Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.
3 years
Number of Participants Reported Distant Recurrence at 3 Years
Periodo de tiempo: 3 years
Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant> metastatic disease (other organs).
3 years
Mortality Rates at 30- and 90-day After Sublobar Resection
Periodo de tiempo: 90 days
90 days
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
Periodo de tiempo: 90 days
Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
90 days
Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection
Periodo de tiempo: 90 days
The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.
90 days
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Periodo de tiempo: 24 months
Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.
24 months
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Periodo de tiempo: 24 months
Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..
24 months
FEV1% Measured at Baseline and Month 3
Periodo de tiempo: 3 months
Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms
3 months
DLCO% Measured at Baseline and Month 3
Periodo de tiempo: 3 months

Pulmonary function tests included percentage predicted carbon

> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms.
3 months

Colaboradores e Investigadores

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

Patrocinador

Alliance for Clinical Trials in Oncology

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: Hiran C. Fernando, MD, Boston Medical Center

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

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 (Actual)

1 de julio de 2005

Finalización primaria (Actual)

18 de abril de 2013

Finalización del estudio (Actual)

15 de febrero de 2019

Fechas de registro del estudio

Enviado por primera vez

5 de abril de 2005

Primero enviado que cumplió con los criterios de control de calidad

5 de abril de 2005

Publicado por primera vez (Estimar)

6 de abril de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de octubre de 2019

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

4 de octubre de 2019

Última verificación

1 de octubre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ACOSOG-Z4032
  • CDR0000422346 (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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