- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00388115
Radiofrequency Ablation in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in Situ
A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying how well radiofrequency ablation followed by surgery works in treating patients with early invasive breast cancer or ductal carcinoma in situ.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the effectiveness of radiofrequency ablation (RFA), in terms of amount of tumor coagulated and viable cell count, in patients with early invasive breast cancer or low- or intermediate-grade ductal carcinoma in situ.
Secondary
- Determine the size, configuration, and pathological features of human breast tumors after treatment with RFA.
- Determine whether RFA energy applied to breast cancer will result in cancer cell death.
- Determine whether tumor-free margins are achieved by RFA in these patients.
- Determine the rate of acute toxicities to skin after surgery in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Pre-radiofrequency ablation (RFA) procedures: Patients undergo staging by MRI assessment to determine the size of their tumor. Patients with nonpalpable lesions must undergo placement of a metallic clip in the center of their tumor and a hook wire to guide surgical excision by intraoperative ultrasound imaging. Patients with invasive breast cancer undergo axillary lymph node dissection or sentinel lymph node biopsy (SLNB) for axillary lymph node staging. Patients with ductal carcinoma in situ proceed directly to RFA/resection since they do not require axillary staging.
- RFA: Patients undergo RFA comprising insertion of a multiple-needle electrode into the breast tumor under direct guidance of ultrasonography and the metallic clip placed preoperatively in the lesion.
- Surgical resection of RFA area: After RFA is completed, the electrode is removed and patients undergo wide local excision of the residual tumor or mastectomy.
After completion of study therapy, patients are followed periodically for up to 4 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Females of ages ≥18 years.
- Core biopsy proven invasive breast cancer OR
- Core biopsy proven low or intermediate grade DCIS.
- Tumor less than or equal to 2.0 cm in diameter.
- No prior surgical treatment for breast cancer within 30 days.
- Life expectancy of > 10 years, not including the diagnosis of cancer.
- ECOG performance status of 0-2.
- Informed consent given.
- Multifocal invasive breast cancer patients are eligible. All tumors that are palpable or visualized by USS can be treated.
Exclusion Criteria:
- Male subjects.
- Ages < 18 years.
- Breast tumor > 2.0 cm in diameter.
- Evidence of distant metastatic disease.
- Evidence of diffuse calcification suggestive of extensive or multifocal DCIS.
- High grade DCIS or presence of comedo-necrosis because these lesions can be associated with invasive breast cancer, which would go undetected if the lesion is entirely destroyed by the RF ablation.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: RFA prior to surgery
|
Standard of care lumpectomy or mastectomy following RFA
Standard of care lumpectomy or mastectomy following RFA
A small diameter needle is inserted through the skin and directly into the tumor for the purpose of supplying RF current.
Initial power of the RF generator will start at 5-10 watts.
The power will increase by 5-10 watts every minute until impedance of the system automatically stops the RF treatment.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number and proportion of patients with viable cancer cells remaining in the resected specimen as measured by enzyme cell viability analysis and amount of tumor coagulated at post-treatment biopsy
Periodo de tiempo: At completion of study
|
At completion of study
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy
Periodo de tiempo: At completion of study
|
At completion of study
|
Number and proportion of patients with and without tumor in the margin
Periodo de tiempo: At completion of study
|
At completion of study
|
Rate of acute skin toxicity
Periodo de tiempo: At completion of study
|
At completion of study
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Vijay Khatri, MD, University of California, Davis
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000505536
- P30CA093373 (Subvención/contrato del NIH de EE. UU.)
- UCD-123 (Otro identificador: University of California, Davis - Cancer Center)
- UCD-200210277-6 (Otro identificador: University of California, Davis - IRB)
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 Cáncer de mama
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University y otros colaboradoresTerminadoLa guía de aplicación clínica de Conebeam Breast CTPorcelana
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
Ensayos clínicos sobre conventional surgery
-
Seattle Children's HospitalJohns Hopkins University; Duke University; Vanderbilt University; University of Utah y otros colaboradoresReclutamientoEscoliosis idiopática | Espondilolistesis | Escoliosis; Adolescencia | Cifosis | Juvenil; Escoliosis | Escoliosis; CongénitaEstados Unidos
-
AGO Study GroupCancer Research UK; ARCAGY/ GINECO GROUP; Grupo Español de Investigación en Cáncer... y otros colaboradoresTerminadoCáncer de ovarios | Cáncer de trompa de Falopio | Cáncer de cavidad peritonealEspaña, Francia, Dinamarca, Bélgica, Alemania, Austria, Porcelana, Italia, Corea, república de, Noruega, Suecia, Reino Unido
-
Kocaeli Derince Education and Research HospitalKocaeli UniversityDesconocidoRecuperación mejorada después de la cirugía | Cirugía a corazón abiertoPavo
-
University of TriesteTerminado
-
Dr. Faruk SemizInscripción por invitación
-
National Cancer Centre, SingaporeTerminadoEnfermedades de la tiroidesSingapur
-
Ethicon Endo-SurgeryTerminadoObesidadEstados Unidos, Alemania
-
University of Illinois at ChicagoEthicon Endo-SurgeryRetiradoEnfermedades del colon y del rectoEstados Unidos
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationTerminadoCáncer de pulmón de células no pequeñasCanadá
-
Assistance Publique - Hôpitaux de ParisDesconocidoCirugía | Artroplastia total de rodilla | Colectomía | HisterectomíaFrancia