- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00095927
Randomized Amifostine For SCCHN
Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form.
The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Maine
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Sanford, Maine, Estados Unidos, 04703
- Goodall Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Concord, Massachusetts, Estados Unidos, 01742
- Bethke Cancer Center at Emerson Hospital
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Danvers, Massachusetts, Estados Unidos, 01923
- Mass General/North Shore Cancer Center
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Fall River, Massachusetts, Estados Unidos, 02721
- Saint Anne's Hospital - Fall River
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Lowell, Massachusetts, Estados Unidos, 01854
- Lowell General Hospital
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New Hampshire
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Dover, New Hampshire, Estados Unidos, 03820
- Wentworth Douglass Hospital
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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
- Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated.
- Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary SCC in the neck will also be eligible.
- Stage 2, 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound or CT (in case of liver function test abnormalities); bone scan in case of local symptoms.
- At least one uni- or bidimensionally measurable lesion at the start of all therapy (induction therapy ag well as chemoradiation).
- No previous head and neck radiotherapy and no previous curative surgery for SCCHN (other than biopsy) are allowed at time of study entry.
- Age ≥ 18 years.
- WHO performance status of 0 or 1 (section 13, Appendix I)
- No active alcohol addiction (as assessed by medical caregiver).
- Life expectancy ≥ 12 weeks.
- Signed informed consent prior to beginning protocol specific procedures.
Adequate bone marrow, hepatic and renal functions as evidenced by the following:
Hematology:
- neutrophil count ≥ 2.0 x 10 9/1.
- platelet count ≥ 100 x 10 9/1.
- hemoglobin ≥ 10 g/dl.
Hepatic function:
- total bilinthin WNL.
- ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x 1JLN.
- alkaline phosphatase ≤ 5 x ULN.
- patients with ASAT or ALAT > 1.5 x ULN associated with alkaline phosphatase > 2.5
- x ULN are not eligible for the study.
Renal function: the creatinine clearance ≥ 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows:
- Weight(kg) x (140 - age)/K x serum creatinine
serum creatinine in mg/dL
- K: 72 in man
- K: 85 in woman
serum creatinine in µmon/L
- K: 0.814 in man
- K: 0.96 in woman
- Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centers
- Previous chemotherapy is permitted, provided that it is in induction form before starting radiation therapy and that it is being used to treat head and neck cancers.
Exclusion Criteria:
- Pregnant or lactating women, or women of childbearing potential not using adequate contraception.
- Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 3 years.
- Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria.
Other serious illnesses or medical conditions including but not limited to:
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurologic or psychiatric disorders including dementia or seizures.
- Active uncontrolled infection.
- Active peptic ulcer.
- Hypercalcemia.
- Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
- Patients requiring intravenous alimentation.
- Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry (unless purposeful)
- Concurrent treatment with any other anticancer therapy.
- Participation in an investigational trial within 30 days of study entry.
- Previous treatment with any biologic therapy is not permitted.
Plan de estudios
¿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 |
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Comparador activo: Arm A Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received;
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Dado IV
Otros nombres:
Dado IV
Otros nombres:
Administrado por vía subcutánea
Otros nombres:
Given once daily for 4 weeks and then twice daily for 2 weeks.
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Experimental: Arm B No-Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN - 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). |
Dado IV
Otros nombres:
Dado IV
Otros nombres:
Given once daily for 4 weeks and then twice daily for 2 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Rate of local/regional control (LRC) 1 year after beginning treatment
Periodo de tiempo: One year after beginning of treatment
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One year after beginning of treatment
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Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months
Periodo de tiempo: 3, 6 Months
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3, 6 Months
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Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy
Periodo de tiempo: End of Radiotherapy
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End of Radiotherapy
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Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment
Periodo de tiempo: 8,12, 24 and 52 weeks
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8,12, 24 and 52 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment
Periodo de tiempo: 8, 12, 24, and 52 weeks
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8, 12, 24, and 52 weeks
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Proportion of patients with PEG dependency
Periodo de tiempo: 3, 6, and 12 months after completion of study treatment
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3, 6, and 12 months after completion of study treatment
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Time to disease progression
Periodo de tiempo: baseline to disease progression
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Kaplan and Meier
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baseline to disease progression
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Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey
Periodo de tiempo: baseline, 8, 12, 24, and 52 weeks after completion of study treatment
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baseline, 8, 12, 24, and 52 weeks after completion of study treatment
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LRC and overall survival at 2 years after completion of study treatment
Periodo de tiempo: 2 Years after completion of study treatment
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2 Years after completion of study treatment
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Swallowing function
Periodo de tiempo: 2 years Post treatment
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2 years Post treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert I. Haddad, MD, Dana-Farber Cancer Institute
Publicaciones y enlaces útiles
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
- cáncer de cuello escamoso metastásico no tratado con tumor primario oculto
- cáncer de cuello escamoso metastásico con carcinoma de células escamosas primario oculto
- Carcinoma de células escamosas de labio y cavidad oral en estadio III
- Carcinoma de células escamosas de labio y cavidad oral en estadio IV
- Carcinoma de células escamosas de orofaringe en estadio III
- Carcinoma de células escamosas de la orofaringe en estadio IV
- Carcinoma epidermoide de hipofaringe en estadio III
- Carcinoma de células escamosas de hipofaringe en estadio IV
- Carcinoma de células escamosas de laringe en estadio III
- Carcinoma de células escamosas de laringe en estadio IV
- Carcinoma de células escamosas en estadio III del seno paranasal y la cavidad nasal
- Carcinoma de células escamosas en estadio IV del seno paranasal y la cavidad nasal
- toxicidad de la radiación
- mucositis
- Carcinoma de células escamosas de labio y cavidad oral en estadio II
- Carcinoma de células escamosas de seno paranasal y cavidad nasal en estadio II
- Carcinoma de células escamosas de hipofaringe en estadio II
- Carcinoma de células escamosas de laringe en estadio II
- Carcinoma de células escamosas de la orofaringe en estadio II
- xerostomía
- toxicidad del agente quimioterapéutico
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Enfermedades Gastrointestinales
- Gastroenteritis
- Enfermedades Estomatognáticas
- Enfermedades de la Boca
- Enfermedades de las glándulas salivales
- Neoplasias de Cabeza y Cuello
- Mucositis
- Xerostomía
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes Protectores
- Agentes antineoplásicos, fitogénicos
- Agentes de protección contra la radiación
- Carboplatino
- Paclitaxel
- Amifostina
Otros números de identificación del estudio
- 03018
- P30CA006516 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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