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Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

10 de abril de 2013 actualizado por: Gynecologic Oncology Group

Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

  • Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy.
  • Compare the toxicity of these regimens in these patients.
  • Compare the health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted.

    • Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.

      • Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses.
      • Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy.
      • Group 3: Patients receive further treatment at the discretion of the investigator.

    • Completed hysterectomy: Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.

      • Group A: Patients receive treatment as in group 1 above without intracavity irradiation.
      • Group B: Patients receive treatment as in group 2 above without intracavity irradiation.
      • Group C: Patients receive no further treatment.
  • Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses.

Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.

Tipo de estudio

Intervencionista

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

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85006-2726
        • CCOP - Western Regional, Arizona
    • California
      • Los Angeles, California, Estados Unidos, 90095-1740
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Gatos, California, Estados Unidos, 95032
        • Women's Cancer Center at Community Hospital of Los Gatos
      • Orange, California, Estados Unidos, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06520-8028
        • Yale Comprehensive Cancer Center
    • Delaware
      • Newark, Delaware, Estados Unidos, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20307-5001
        • Walter Reed Army Medical Center
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Estados Unidos, 60612
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, Estados Unidos, 60612-3824
        • Rush-Presbyterian-St. Luke's Medical Center
      • Decatur, Illinois, Estados Unidos, 62794-9640
        • CCOP - Central Illinois
      • Evanston, Illinois, Estados Unidos, 60201
        • CCOP - Evanston
      • Urbana, Illinois, Estados Unidos, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202-5289
        • Indiana University Cancer Center
      • South Bend, Indiana, Estados Unidos, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • CCOP - Grand Rapids
      • Kalamazoo, Michigan, Estados Unidos, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • CCOP - Metro-Minnesota
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Estados Unidos, 64131
        • CCOP - Kansas City
      • Springfield, Missouri, Estados Unidos, 65807
        • CCOP - Cancer Research for the Ozarks
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • New Jersey
      • Camden, New Jersey, Estados Unidos, 08103-1489
        • Cooper University Hospital
    • New York
      • New York, New York, Estados Unidos, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook, New York, Estados Unidos, 11790-7775
        • Long Island Cancer Center at Stony Brook University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45267-0526
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, Estados Unidos, 44106
        • Ireland Cancer Center
      • Columbus, Ohio, Estados Unidos, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Oregon
      • Portland, Oregon, Estados Unidos, 97225
        • CCOP - Columbia River Oncology Program
    • Pennsylvania
      • Abington, Pennsylvania, Estados Unidos, 19001-3788
        • Abington Memorial Hospital
      • Danville, Pennsylvania, Estados Unidos, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Hershey, Pennsylvania, Estados Unidos, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
        • Abramson Cancer Center at University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213-3180
        • Magee-Womens Hospital
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37917
        • Southeast Gynecologic Oncology Associates
      • Nashville, Tennessee, Estados Unidos, 37232-2516
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Galveston, Texas, Estados Unidos, 77555-0587
        • University of Texas Medical Branch
      • Houston, Texas, Estados Unidos, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Temple, Texas, Estados Unidos, 76508
        • CCOP - Scott and White Hospital
    • Vermont
      • Burlington, Vermont, Estados Unidos, 05401
        • Fletcher Allen Health Care - Medical Center Campus
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792-6188
        • University of Wisconsin Comprehensive Cancer Center
  • Japón
      • Kagoshima City, Japón, 892-8580
        • Kagoshima City 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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Adenosquamous carcinoma
  • Primary, previously untreated disease
  • Exophytic cervical lesions greater than 4 cm in diameter OR
  • Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer
  • No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations)
  • No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection)
  • Eligible for radical hysterectomy and lymph node dissection

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal

Renal

  • Creatinine no greater than 2.0 mg/dL
  • No renal abnormalities requiring modification of radiation fields

Gastrointestinal

  • No gastrointestinal bleeding
  • No intestinal obstruction

Other

  • Not pregnant
  • Negative pregnancy test
  • No septicemia or severe infection
  • No other invasive malignancy with any evidence of disease within the past 5 years except nonmelanoma skin cancer
  • No circumstances that would preclude study completion or required follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
  • No prior hysterectomy (total or subtotal)

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

Colaboradores e Investigadores

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

Patrocinador

Gynecologic Oncology Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: D. Scott McMeekin, MD, Oklahoma University Cancer Institute

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 febrero de 2003

Finalización primaria (Actual)

1 de abril de 2005

Fechas de registro del estudio

Enviado por primera vez

5 de febrero de 2003

Primero enviado que cumplió con los criterios de control de calidad

5 de febrero de 2003

Publicado por primera vez (Estimar)

6 de febrero de 2003

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de abril de 2013

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

10 de abril de 2013

Última verificación

1 de abril de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000269821
  • GOG-0201

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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