- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02070393
Breast-Sparing Proton Therapy for Hodgkin's Disease (Breast Sparing)
Breast-Sparing Proton Therapy for Hodgkin's Disease in Young Females Demonstrated By Positron Emission Tomograpy (PET) Scanning: A Pilot Study
Descripción general del estudio
Descripción detallada
According to the National Cancer Institute's Surveillance, Epidemiology, and End Results Program, there will be an estimated 8,490 new cases of Hodgkin's Lymphoma (HL) in the United States in 2010, with an estimated 1,320 deaths (Jemal, Siegel et al.). The unadjusted rates of 5 year overall survival are approximately 95%, and remain among the highest of all childhood and adult malignancies. With many children and young adults surviving into advanced age, the impetus has been to develop less toxic yet equally effective treatments. One of the main approaches taken over the last 25 years to minimize long-term treatment toxicity has been to limit the amount and volume of radiation received by patients. This pilot study continues along those lines, attempting to further refine the delivery of radiation therapy (RT) in order to avoid one of the most notorious long-term side-effects: secondary breast cancer.
Multiple studies investigating late toxicity in long-term survivors of pediatric Hodgkin's Lymphoma have shown the risk of breast cancer in young females receiving mediastinal radiation to be 50 times greater than their age-matched counterparts. The Late Effects Study Group, with a median follow-up of 17 years, reported a breast cancer incidence of 16% with a standardized incidence ratio of 55.5 (Bhatia, Yasui et al. 2003). Through utilization of breast-sparing proton therapy, we hope to provide young female patients with the benefits of radiation therapy while decreasing their risk of secondary breast cancer, thus increasing the therapeutic ratio.
In a prior computer-based, in-silico, dose planning study, utilizing the most basic beam orientation (a single PA beam), we showed that dose to breast tissue was reduced by a minimum of at least 80% with proton treatment compared to standard AP-PA photon treatment (in publication). Furthermore, dose to clinical target volume was maintained, and dose to other normal structures was statistically no worse. We now aim to validate these findings by verifying the beam range, in-vivo, via post-treatment combined Positron Emission Tomography-Computer Tomography (PET-CT) imaging in young females undergoing supra-diaphragmatic radiotherapy for Hodgkin's Disease.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Bloomington, Indiana, Estados Unidos, 47408
- Indiana University Health Proton Therapy Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female sex
- Age >/= 10 years old and < 30 years old
- Pathologically confirmed classical Hodgkin's Lymphoma
- At least one site of disease located above the diaphragm
- Signed study-specific consent prior to initiation of therapy
- Women of child-bearing potential must have a negative pregnancy blood test within 7 days of starting protocol therapy.
Exclusion Criteria:
- Previous radiation therapy to any part of the body.
- Parenchymal lung involvement at initial presentation or any patient that may need whole lung irradiation as per institutional guidelines.
- Lymphocyte predominant histology not eligible.
Significant infection or other coexistent medical condition that would preclude protocol therapy such as:
- History of HIV/AIDS
- History of collagen Vascular Disease
- Symptomatic congestive heart failure
- Unstable angina pectoris or myocardial infarction within 6 months
- Uncontrolled hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg on 2 consecutive measurements separated by 1 week).
- History of uncontrolled diabetes
- Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Radiation Treatment using Protons
14 -24 Radiation Treatments (typically 1.5 - 1.8 cobalt-Gray equivalent per fraction for 14-24 treatments).
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14-24 Radiation treatments using Protons
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues.
Periodo de tiempo: 12 months
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Dose-volume histogram data from both the delivered proton plan and the accompanying photon plan for target volumes and normal tissues, including: • Breast, heart, lung, thyroid, parotid glands , esophagus, spinal cord, *liver, *kidneys, |
12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Treatment toxicity and disease control of proton therapy for the treatment of pediatric Hodgkin's Lymphoma.
Periodo de tiempo: 3 - 60 Months
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3 - 60 Months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeffery Buchsbuam, MD, Indiana University
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IUHPTC-01
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. .
Ensayos clínicos sobre Enfermedad de Hodgkin
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GALIA AVRAHAMIUniversity of GiessenReclutamientoLinfoma de Hodgkins clásico en niños y adolescentes.Israel
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Millennium Pharmaceuticals, Inc.Johnson & Johnson Pharmaceutical Research & Development, L.L.C.TerminadoTumores | Linfoma no HodgkinsEstados Unidos
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University of PennsylvaniaTerminadoPacientes con linfoma no Hodgkins (LNH), con linfomas de células B CD19+Estados Unidos
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National Cancer Institute (NCI)TerminadoLinfoma de células B | Leucemia de células B | Linfoma de Hodgkins | Linfoma No HodgkinEstados Unidos
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AstraZenecaTerminadoLinfoma periférico de células T en recaída/refractario | Linfoma de Hodgkins clásico en recaída/refractarioItalia, Suecia, Estados Unidos, Taiwán, Corea, república de, Reino Unido, Australia, Francia, Singapur
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ModernaTX, Inc.AstraZenecaActivo, no reclutandoAumento de la dosis: neoplasias malignas o linfomas de tumores sólidos en recaída/refractarios | Expansión de dosis: cáncer de mama triple negativo, HNSCC, cáncer no Hodgkins, cáncer urotelial, melanoma resistente al punto de control inmunitario y linfoma NSCLCEstados Unidos, Israel, Australia
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Medical College of WisconsinTerminadoLinfoma No Hodgkin | Linfoma de Hodgkins | Leucemia Linfocítica Aguda | Leucemia Mielocítica Aguda | Leucemia Mieloide Crónica | Leucemia Linfocítica Crónica
Ensayos clínicos sobre Proton
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Washington University School of MedicineReclutamientoCáncer metastásico | Tumor sólido irresecableEstados Unidos
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University of FloridaTerminadoCáncer de mamaEstados Unidos
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Loma Linda UniversityTerminadoCancer de pancreasEstados Unidos