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A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

management of therapy complications

+ radiation therapy

ProcedimientoRadiación
Quiénes están siendo reclutados

Carcinoma+5

+ Carcinoma de Células Escamosas

+ Neoplasias

De 16 a 120 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Cuidados de Apoyo

Fase 3
Intervencional
Inicio del estudio: agosto de 1999
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNCIC Clinical Trials Group
Última actualización: 6 de abril de 2020
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 2 de agosto de 1999

Fecha en la que se inscribió al primer participante.

OBJECTIVES: Compare the toxicity of radiotherapy to the oral mucosa delivered in the morning or in the late afternoon in patients with squamous cell carcinoma of the oral cavity, pharynx (oro/hypo/naso), or larynx who will receive radiation treatment to a significant part of the oral and/or oropharyngeal mucosa. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, intended smoking behavior during therapy (smoking vs nonsmoking), and planned total radiotherapy dose. Patients are randomized to receive radiotherapy once daily, 5 days a week, at one of two of the following times of the day: Arm I: Patients receive radiotherapy between 8 and 10 AM (local time). Arm II: Patients receive radiotherapy between 4 and 6 PM (local time). Treatment continues for 5-8 weeks, depending on planned total radiotherapy dose, in the absence of unacceptable toxicity or disease progression. Toxicity is assessed at baseline, at the first fraction of radiotherapy, weekly during treatment, weekly until mucositis has peaked and is improving, and then every 2 weeks until mucositis has improved to less than grade 2. Quality of life is assessed at baseline, weekly during treatment and until toxicity has peaked and is improving, every 2 weeks until toxicity is less than grade 2 mucositis, and then at each follow-up visit until week 24. Patients are followed at weeks 2-3, 6-8, 12, and 24 and then annually for 3 years. PROJECTED ACCRUAL: A total of 216 patients (108 per treatment arm) will be accrued for this study.

NCT00004234
Patrocinador PrincipalNCIC Clinical Trials Group
Última actualización: 6 de abril de 2020
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.

Estudio de Cuidados de Apoyo

Estos estudios exploran maneras de mejorar el confort y la calidad de vida diaria de las personas que viven con una condición. Pueden centrarse en aliviar síntomas, reducir efectos secundarios del tratamiento o apoyar el bienestar general.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 16 a 120 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

CarcinomaCarcinoma de Células EscamosasNeoplasiasNeoplasias por tipo histológicoNeoplasias por SitioNeoplasias glandulares y epitelialesCarcinoma de células escamosas de cabeza y cuelloNeoplasias de cabeza y cuello

Criterios

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical radiotherapy TX, T1-4, NX, N0-3, M0 Directly visible area of mucosa including 2 or more protocol specified anatomical locations in the radical target volume At least 6 cm^2 in area irrespective of shape No M1 disease Intention to deliver radiotherapy to a radical dose without chemotherapy May have had surgical resection of the primary or neck nodes Postoperative macroscopic or microscopic residual disease that is eligible for radical radiotherapy is allowed Patients with completely resected disease who are judged to be at high risk of relapse and who are eligible for radical radiotherapy are allowed PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin ≥ 10 g/dL Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative Must have normal sleeping habits (i.e., normal circadian rhythm) Must have had dental assessment and necessary prophylactic dental extractions carried out No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective tissue disease, rheumatoid arthritis) No organic brain syndrome related to chronic alcohol excess or other cause of sufficient severity that would preclude cooperation with treatment No active uncontrolled infection No history of psychiatric or neurological disorder that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 6 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the head and neck region Surgery: See Disease Characteristics Other: No other concurrent oral hygiene regimen other than that described in the protocol No concurrent radioprotective drugs or therapy

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 14 ubicaciones

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, CanadaAbrir British Columbia Cancer Agency - Centre for the Southern Interior en Google Maps

Fraser Valley Centre at Surrey Memorial Hospital

Surrey, Canada

British Columbia Cancer Agency

Vancouver, Canada

CancerCare Manitoba

Winnipeg, Canada
Completado14 Centros de Estudio