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Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

26 de junio de 2013 actualizado por: Radiation Therapy Oncology Group

A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy, cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone.

Secondary

  • Compare progression-free survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare quality of life, functional/performance status, and quality-adjusted survival of patients treated with these regimens.

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

  • Arm I: Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour and cisplatin IV over 30 minutes once daily on days 1-5, 15-19, 29-33, and 43-47. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-13, 20-27, 34-41, and 48-55.

  • Arm II: Patients receive 1 of the following cisplatin-based* regimens at the discretion of the treating physician:

    • Regimen 1: Patients receive cisplatin* IV over 1-2 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4.
    • Regimen 2: Patients receive cisplatin* IV over 1-2 hours and paclitaxel IV over 3 hours on day 1.
    • Regimen 3: Patients receive cisplatin* IV over 1-2 hours and docetaxel IV over 1 hour on day 1.

NOTE: *Carboplatin may be substituted for cisplatin in patients with creatinine clearance < 50 mL/min or in patients who experience grade 2 or 3 neurotoxicity.

For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond documentation of CR.

Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study within 5½ years.

Tipo de estudio

Intervencionista

Inscripción (Actual)

15

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
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Mobile, Alabama, Estados Unidos, 36652-2144
        • Mobile Infirmary Medical Center
    • Arkansas
      • Hot Springs, Arkansas, Estados Unidos, 71913
        • St. Joseph's Mercy Cancer Center
    • California
      • Auburn, California, Estados Unidos, 95603
        • Auburn Radiation Oncology
      • Cameron Park, California, Estados Unidos, 95682
        • Radiation Oncology Centers - Cameron Park
      • Carmichael, California, Estados Unidos, 95608
        • Mercy Cancer Center at Mercy San Juan Medical Center
      • Pomona, California, Estados Unidos, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Roseville, California, Estados Unidos, 95661
        • Radiation Oncology Center - Roseville
      • Sacramento, California, Estados Unidos, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
      • Sacramento, California, Estados Unidos, 95819
        • Mercy General Hospital
      • Sacramento, California, Estados Unidos, 95817
        • University of California Davis Cancer Center
      • Vacaville, California, Estados Unidos, 95687
        • Solano Radiation Oncology Center
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Gainesville, Florida, Estados Unidos, 32610-0232
        • University of Florida Shands Cancer Center
      • Jupiter, Florida, Estados Unidos, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Miami Beach, Florida, Estados Unidos, 33140
        • CCOP - Mount Sinai Medical Center
      • Tampa, Florida, Estados Unidos, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30912
        • MBCCOP - Medical College of Georgia Cancer Center
      • Savannah, Georgia, Estados Unidos, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Illinois
      • Alton, Illinois, Estados Unidos, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Aurora, Illinois, Estados Unidos, 60507
        • Rush-Copley Cancer Care Center
      • Joliet, Illinois, Estados Unidos, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Olympia Fields, Illinois, Estados Unidos, 60461
        • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
      • Springfield, Illinois, Estados Unidos, 62702
        • Cancer Institute at St. John's Hospital
      • Urbana, Illinois, Estados Unidos, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, Estados Unidos, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Anderson, Indiana, Estados Unidos, 46016
        • St. John's Cancer Center at St. John's Medical Center
      • Beech Grove, Indiana, Estados Unidos, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Elkhart, Indiana, Estados Unidos, 46515
        • Elkhart General Hospital
      • Indianapolis, Indiana, Estados Unidos, 46202-5289
        • Indiana University Cancer Center
      • Kokomo, Indiana, Estados Unidos, 46904
        • Howard Community Hospital at Howard Regional Health System
      • La Porte, Indiana, Estados Unidos, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, Estados Unidos, 46360
        • Saint Anthony Memorial Health Centers
      • Richmond, Indiana, Estados Unidos, 47374
        • Reid Hospital & Health Care Services, Incorporated
      • South Bend, Indiana, Estados Unidos, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Estados Unidos, 46601
        • CCOP - Northern Indiana CR Consortium
    • Louisiana
      • Shreveport, Louisiana, Estados Unidos, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Maine
      • Waterville, Maine, Estados Unidos, 04901
        • MaineGeneral Medical Center - Waterville Campus
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Michigan
      • Adrian, Michigan, Estados Unidos, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Estados Unidos, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Estados Unidos, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Lansing, Michigan, Estados Unidos, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • St. Joseph, Michigan, Estados Unidos, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
    • Missouri
      • Cape Girardeau, Missouri, Estados Unidos, 63701
        • Saint Francis Medical Center
      • Gape Girardeau, Missouri, Estados Unidos, 63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Saint Louis, Missouri, Estados Unidos, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • St Louis, Missouri, Estados Unidos, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • St. Louis, Missouri, Estados Unidos, 63141
        • CCOP - St. Louis-Cape Girardeau
    • Montana
      • Billings, Montana, Estados Unidos, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Estados Unidos, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Estados Unidos, 59107-7000
        • Deaconess Billings Clinic - Downtown
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68114
        • Methodist Cancer Center at Methodist Hospital - Omaha
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Keene, New Hampshire, Estados Unidos, 03431
        • Kingsbury Center for Cancer Care at Cheshire Medical Center
      • Lebanon, New Hampshire, Estados Unidos, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Marlton, New Jersey, Estados Unidos, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Toms River, New Jersey, Estados Unidos, 08755
        • J. Phillip Citta Regional Cancer Center at Community Medical Center
      • Vineland, New Jersey, Estados Unidos, 08360
        • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
      • Voorhees, New Jersey, Estados Unidos, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • Brooklyn, New York, Estados Unidos, 11201
        • Long Island College Hospital
      • Buffalo, New York, Estados Unidos, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, Estados Unidos, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Estados Unidos, 11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • New Hyde Park, New York, Estados Unidos, 11042
        • Long Island Jewish Medical Center
    • North Carolina
      • Kinston, North Carolina, Estados Unidos, 28501
        • Lenoir Memorial Cancer Center
      • Rutherfordton, North Carolina, Estados Unidos, 28139
        • Rutherford Hospital
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Cancer Care Center at Medcenter One Hospital
      • Bismarck, North Dakota, Estados Unidos, 58502
        • St. Alexius Medical Center
    • Ohio
      • Akron, Ohio, Estados Unidos, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Akron, Ohio, Estados Unidos, 44309-2090
        • Akron City Hospital
      • Dayton, Ohio, Estados Unidos, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, Estados Unidos, 45405
        • Grandview Hospital
      • Dayton, Ohio, Estados Unidos, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Estados Unidos, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Estados Unidos, 45429
        • CCOP - Dayton
      • Findlay, Ohio, Estados Unidos, 45840
        • Blanchard Valley Medical Associates
      • Kettering, Ohio, Estados Unidos, 45429
        • Charles F. Kettering Memorial Hospital
      • Lima, Ohio, Estados Unidos, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Estados Unidos, 43623
        • Northwest Ohio Oncology Center
      • Middletown, Ohio, Estados Unidos, 45044
        • Middletown Regional Hospital
      • Oregon, Ohio, Estados Unidos, 43616
        • St. Charles Mercy Hospital
      • Salem, Ohio, Estados Unidos, 44460
        • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
      • Sandusky, Ohio, Estados Unidos, 44870
        • Firelands Regional Medical Center
      • Sylvania, Ohio, Estados Unidos, 43560
        • Flower Hospital Cancer Center
      • Toledo, Ohio, Estados Unidos, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Estados Unidos, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Estados Unidos, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, Estados Unidos, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Troy, Ohio, Estados Unidos, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wooster, Ohio, Estados Unidos, 44691
        • Cancer Treatment Center
      • Wright-Patterson Afb, Ohio, Estados Unidos, 45433-5529
        • United States Air Force Medical Center - Wright-Patterson
      • Xenia, Ohio, Estados Unidos, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Pennsylvania
      • Darby, Pennsylvania, Estados Unidos, 19023
        • Mercy Fitzgerald Hospital
      • Natrona Heights, Pennsylvania, Estados Unidos, 15065
        • Alle-Kiski Medical Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, Estados Unidos, 19141
        • Albert Einstein Cancer Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
    • South Carolina
      • Anderson, South Carolina, Estados Unidos, 29621
        • AnMed Health Cancer Center
      • Charleston, South Carolina, Estados Unidos, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Rapid City, South Dakota, Estados Unidos, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Estados Unidos, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, Estados Unidos, 57105
        • Medical X-Ray Center, PC
    • Utah
      • Murray, Utah, Estados Unidos, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, Estados Unidos, 84403
        • 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, 84106
        • Utah Cancer Specialists at UCS Cancer Center
      • Salt Lake City, Utah, Estados Unidos, 84143
        • Latter Day Saints Hospital
    • Vermont
      • Saint Johnsbury, Vermont, Estados Unidos, 05819
        • Norris Cotton Cancer Center - North
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Menomonee Falls, Wisconsin, Estados Unidos, 53051
        • Community Memorial Hospital Cancer Care Center
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, Estados Unidos, 53215
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
      • Racine, Wisconsin, Estados Unidos, 53405
        • All Saints Cancer Center at Wheaton Franciscan Healthcare
      • Wausau, Wisconsin, Estados Unidos, 54401
        • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
      • West Milwaukee, Wisconsin, Estados Unidos, 53227
        • West Allis 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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

DISEASE CHARACTERISTICS:

  • Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants:

    • Spindle cell carcinoma
    • Poorly differentiated keratin-positive carcinoma
    • Lymphoepithelioma NOTE: *Biopsy or primary tumor and/or fine needle aspiration of the metastatic lymph node required

  • Original or second primary tumor

    • Recurrent neck metastases with unknown primary allowed
  • Locally recurrent disease
  • Measurable disease

  • Unresectable disease

    • Attempted surgical resection allowed provided surgery was performed ≥ 3 months ago, wound is completely healed, and there is no sign of carotid exposure

  • Must have had prior radiotherapy for SCC of the head and neck with > 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy

    • Able to successfully re-irradiate the area of the gross tumor volume without exceeding lifetime spinal cord dose of 54 Gy as determined by physical examination and CT scan and/or MRI performed within the past 8 weeks

    • First recurrence occurred > 6 months after completion of radiotherapy

      • More than 1 recurrence allowed provided the above criteria for first recurrence has been met
  • No primary tumor of the nasopharynx or salivary gland

  • No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site

    • Patients with equivocal pulmonary nodules are eligible provided the nodules are < 1 cm, can be safely biopsied, or are negative by positron emission tomography imaging
    • No circumferential tumor involvement of the carotid sheath by imaging unless prophylactic carotid stent is placed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,800/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

Hepatic

  • AST or ALT < 2 times upper limit of normal (ULN)
  • Bilirubin < 1.5 mg/dL
  • No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

Renal

  • Creatinine clearance > 50 mL/min
  • Calcium < 11.5 mg/dL

Cardiovascular

  • No New York Heart Association class III or IV heart disease
  • No other symptomatic or uncontrolled cardiac disease

Pulmonary

  • No chronic obstructive pulmonary disease exacerbation
  • No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy

Immunologic

  • No AIDS
  • No prior allergic reaction to E. coli-derived products
  • No acute bacterial or fungal infection requiring IV antibiotics

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix
  • No pre-existing peripheral sensory neuropathy > grade 2
  • No other severe active co-morbidity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 6 months since prior chemotherapy

  • No prior systemic chemotherapy for recurrent SCC of the head and neck

    • Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • See Chemotherapy
  • At least 6 months since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed
  • At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents
  • No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck
  • No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)

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
Otro: Radiotherapy and chemotherapy
Radiotherapy/paclitaxel/cisplatin/filgrastim
Radiación: radioterapia
Droga: cisplatino
Droga: paclitaxel
Biológico: filgrastim
Otro: Chemotherapy
Cisplatin/fluorouracil/paclitaxel/docetaxel
Droga: docetaxel
Droga: fluorouracilo
Droga: cisplatino
Droga: paclitaxel

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Overall Survival
Periodo de tiempo: Date of death or last follow-up
Date of death or last follow-up

Colaboradores e Investigadores

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

Patrocinador

Radiation Therapy Oncology Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Stuart J. Wong, MD, Medical College of Wisconsin

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 abril de 2005

Finalización primaria (Actual)

1 de febrero de 2009

Fechas de registro del estudio

Enviado por primera vez

7 de junio de 2005

Primero enviado que cumplió con los criterios de control de calidad

7 de junio de 2005

Publicado por primera vez (Estimar)

8 de junio de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de julio de 2013

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

26 de junio de 2013

Última verificación

1 de junio de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RTOG-0421
  • CDR0000429480
  • ECOG-R0421

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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