- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04244708
The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas
Radiotherapy Plus Concomitant Temozolomide for Refractory Pituitary Adenomas,A Randomized,Double-blind, Placebo-controlled Phase II Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Renzhi Wang, Dr.
- Número de teléfono: 86+18611964099
- Correo electrónico: wangrz@126.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Minimum Age: 18 Years Maximum Age: 80 Years
- Age ≥18 years, regardless of gender;
Meet the diagnostic criteria for refractory pituitary tumors;
- The tumor showed invasive growth on imaging and rapid growth, Ki-67 labeling index ≥3%;
- The tumor recurred within a short period of time (< 6months) after total resection;
- The tumor continues to grow after surgery and medical therapy;
- Systemic examination showed no metastases in the cranial canal or other systems throughout the body.
- Clinicopathological diagnosis of pituitary adenoma, and pathological tissue (wax or frozen tissue) can be obtained;
- Expected survival time ≥ 6 months;
- KPS score ≥70 points;
- Subjects who were able to read, understand, and sign written informed consent prior to participating in the study and were willing to comply with protocol requirements.
Exclusion Criteria:
Participants cannot participate in this study if they meet any of the following conditions:
- Subjects participated in clinical studies of other drugs or medical devices within 3 months before screening.
- Known to be allergic to temozolomide capsules;
- Have been diagnosed with pituitary carcinoma or have other malignant tumors;
- Have received radiation therapy for Sella region;
Those with severe acute and chronic diseases in various systems, whose conditions have not been effectively controlled, and whose conditions are unstable, including but not limited to:
- Patients with cardiac insufficiency (NYHA cardiac function grade ≥ 2), patients with severe heart disease such as cardiomyopathy, coronary heart disease, severe arrhythmia, etc. that are not effectively controlled;
- Severe active infections,
- Uncontrollable diabetes, hypertension / hypotension, cerebrovascular disease, gastric ulcer, respiratory disease, active autoimmune disease, etc .;
- History of any other diseases that the researcher judges to be unsuitable for the trial, etc .;
- For hepatic and renal insufficiency, hematological indicators: total bilirubin> 1.5 × ULN, ALT, AST> 2.5 × ULN; serum creatinine> 2 × ULN;
- Those with a neutrophil count of less than 1.5 × 109 / L, or a platelet count of less than 100 × 109 / L, or an HGB of less than 90g / L;
- Hepatitis B surface antigen, anti-HCV, anti-HIV or syphilis antibody positive;
- Those who need to take valproic acid and drugs that can cause bone marrow depression during the application or research period;
- pregnant or lactating women or those planning to become pregnant;
- People with history of difficulty in drawing blood;
- People with a history of bleeding disorders;
- Subjects had a history of drug use or smoking and alcohol abuse within 6 months before enrollment;
- Researchers do not consider it appropriate to participate in the trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Radiotherapy plus temozolomide
Undergoing fractionated radiotherapy at a dose of 2 Gy per fraction given once daily five days per week for a total dose of 54 Gy, plus continuous daily temozolomide (75 mg per square meter of body-surface area per day), followed by six cycles of adjuvant temozolomide.
|
undergoing fractionated radiotherapy at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks, for a total dose of 54 Gy, plus continuous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
|
Comparador de placebos: Radiotherapy plus placebo
Radiotherapy treatment alone undergoing fractionated radiotherapy, total 54 Gy, 2GyX27, received placebo.
|
undergoing fractionated radiotherapy at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks, for a total dose of 54 Gy, plus placebo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tumor size
Periodo de tiempo: Four weeks after concurrent chemoradiotherapy, patients were then to receive three cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days. At the end of Cycle 3 (each cycle is 28 days)
|
A tumor response was defned as a decrease of more than 30% of the largest tumor diameter or stable in Tumor volume
|
Four weeks after concurrent chemoradiotherapy, patients were then to receive three cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days. At the end of Cycle 3 (each cycle is 28 days)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Hormonal responses
Periodo de tiempo: Four weeks after concurrent chemoradiotherapy, patients were then to receive three cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days. At the end of Cycle 3 (each cycle is 28 days)
|
Hormonal response as a 50% or more decrease in baseline hormone levels.
|
Four weeks after concurrent chemoradiotherapy, patients were then to receive three cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days. At the end of Cycle 3 (each cycle is 28 days)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: renzhi Wang, Dr., PUMCH
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Enfermedades del sistema endocrino
- Neoplasias de glándulas endocrinas
- Enfermedades hipotalámicas
- Neoplasias hipotalámicas
- Neoplasias Supratentoriales
- Neoplasias Cerebrales
- Neoplasias del Sistema Nervioso Central
- Neoplasias del Sistema Nervioso
- Adenoma
- Neoplasias hipofisarias
- Enfermedades de la pituitaria
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Temozolomida
Otros números de identificación del estudio
- PekingUMCH-PA-TMZ
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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