- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02476669
Serial Plasma EBV DNA for Nasopharyngeal Carcinoma
Serial Plasma EBV DNA for Patients With Nasopharyngeal Carcinoma
Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China, Hong Kong, Taiwan, Singapore and Malaysia. It is highly associated with Epstein-Barr virus (EBV). Radiation therapy alone is indicated for early stage I to II diseases while concurrent chemoradiation is required for more advanced stage III to IVB diseases. Intensity-modulated radiation therapy (IMRT) is the standard radiation technique for NPC, in virtue of its superior target coverage and dose sparing to adjacent critical organs-at-risks.
Plasma EBV DNA and other novel plasma biomarkers have been extensively investigated in NPC. Previous studies have proven their predictive and prognostic values in NPC diagnosis, surveillance and survival outcomes.
We would like to investigate the roles of plasma biomarkers including plasma EBV DNA on treatment response evaluation, survival and prognosis on NPC, in the modern era of precision radiation therapy. This will provide important information on refining on the current edition of AJCC/UICC staging classification.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Patients with histologically confirmed previously untreated NPC are be recruited to join tis study. The study has obtained approval from local institutional review board.
After written informed consent, baseline investigations including blood tests for routine hematology, biochemistry and plasma EBV DNA will be taken. Only 3ml of EDTA blood will be taken for plasma EBV DNA and other potential biomarkers. They will also undergo baseline imaging investigations including positron-emission tomography with integrated computed tomography (PET-CT) and magnetic resonance imaging (MRI) of the head and neck regions. An routine nasoendoscopy and nasopharyngeal biopsies will be obtained to confirm and delineate the mucosal extent of the disease.
If confirmed non-metastatic, patients will be treated with IMRT using 7-9 radiation beams. A total dose of 70Gy in 33-35 fractions over 6.5 to 7 weeks will be given. For advanced stage III to IVB diseases, concurrent chemoradiation using cisplatin 100mg/m2 on Day 1, 22 and 43 of IMRT followed by 3 cycles of adjuvant chemotherapy with cisplatin 80mg/m2 on Day 1 and 5-FU 1000mg/m2 from Day 1 to Day 4 every 4 weeks for 3 more cycles starting 4 weeks after completion of IMRT will also be given. Some patients will also receive induction chemotherapy with either (1) cisplatin 100mg/m2 on Day 1 and 5-FU 1000mg/m2 on Day 1 to 5, or cisplatin 100mg/m2 on Day 1 and gemcitabine 1000mg/m2 on Day 1 and Day 8, administered every 3 weeks for 3 cycles before commencement of chemoradiation, at the discretion of treating oncologists if their primary tumours are close to critical organs e.g. brainstem, optic chiasm or optic nerves.
After treatment patients will undergo nasopharyngeal biopsies, patients will undergo nasopharyngeal biopsies again at 8 weeks after completion of IMRT to confirm histological complete local remission. Blood will be taken again on the same day for plasma EBV DNA and other potential biomarkers. Additional biopsies and salvage local treatment e.g. brachytherapy, stereotactic or IMRT boost will be offered to patients who have persistent local disease at 12 weeks after completion of IMRT. If complete local remission is confirmed, patient will have regular follow up every 3 to 4 months for surveillance and survival outcomes. Regular imaging with MRI and CT scans every 3 to 4 months will also be arranged as well. Plasma EBV DNA will be measured again at 6 months and 1 year after completion of IMRT and then as clinically indicated afterwards.
For those with metastatic diseases at diagnosis, systemic chemotherapy (platinum-based chemotherapy with cisplatin and gemcitabine) will be offered. Blood taking for plasma EBV DNA and other potential biomarkers at baseline before chemotherapy commencement and then after every 3 cycles will be arranged. Plasma EBV DNA measurement and imaging examinations with CT and MRI scans will be arranged at baseline and then after 3-4 cycles of chemotherapy for tumour response evaluation. If the disease does not show progression according to RECIST 1.1, patients will receive up to 6 cycles of chemotherapy followed by consolidation IMRT to the nasopharynx and the neck with 60-70Gy in 33-35 fractions over 6-7 weeks. Additional stereotactic body radiation therapy (SBRT) will be offered to patients who have oligo-progression/oligo-metastasis (up to 3 lesions). Patients will have regular follow up every 3-4 months afterwards. Further salvage palliative chemotherapy or radiation therapy or best supportive care depending on the patients' wish and performance status will be offered to those who develop further relapse after first-line chemotherapy and/or consolidation IMRT.
The trend of baseline and serial plasma EBV DNA and other potential biomarkers will be monitored prospectively.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Hong Kong, Hong Kong
- Reclutamiento
- Department of Clinical Oncology, Queen Mary Hospital
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Contacto:
- Victor Lee, FRCR
- Número de teléfono: 852-2255-4352
- Correo electrónico: vhflee@hku.hk
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Sub-Investigador:
- Dora Kwong, MD
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Sub-Investigador:
- Chi-Chung Tong, FRCR
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Sub-Investigador:
- Chun-Kin Sze, FRCR
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients with histologically confirmed previously untreated nasopharyngeal carcinoma
Exclusion Criteria:
- Patients who are pregnant or lactating
- Patients who are not mentally capable of giving written informed consent
- Patients with performance status ECOG=3 or above or patients who are expected not able to tolerate radiation therapy and/or chemotherapy
- Patients who refuse active treatment for their nasopharyngeal carcinoma
- Patients who cannot comply with radiation therapy and/or chemotherapy for their nasopharyngeal carcinoma
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall survival
Periodo de tiempo: 3 years
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Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause
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3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Supervivencia libre de progresión
Periodo de tiempo: 3 años
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La supervivencia libre de progresión se calcula desde la fecha de diagnóstico de NPC hasta la fecha de progresión de NPC o la fecha de muerte por cualquier causa, lo que ocurra primero.
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3 años
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Supervivencia libre de metástasis a distancia
Periodo de tiempo: 3 años
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La supervivencia libre de metástasis a distancia se calcula desde la fecha de diagnóstico de NPC hasta la fecha de metástasis a distancia o la fecha de muerte por cualquier causa, lo que ocurra primero.
|
3 años
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Cancer-specific survival
Periodo de tiempo: 3 years
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Cancer-specific survival is calculated from the date of diagnosis of NPC to the date of death due to cancer
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3 years
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Regional failure-free survival
Periodo de tiempo: 3 years
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Regional failure-free survival is calculated from the date of diagnosis of NPC to the date of regional nodal failure or date of death from any cause, whichever comes earlier.
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3 years
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Local failure-free survival
Periodo de tiempo: 3 years
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Local failure-free survival is calculated from the date of diagnosis of NPC to the date of local failure or date of death from any cause.
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3 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Victor Lee, FRCR, The University of Hong Kong
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias faríngeas
- Neoplasias Otorrinolaringológicas
- Neoplasias de Cabeza y Cuello
- Enfermedades Nasofaríngeas
- Enfermedades faríngeas
- Enfermedades Estomatognáticas
- Enfermedades Otorrinolaringológicas
- Neoplasias Nasofaríngeas
- Carcinoma
- El carcinoma nasofaríngeo
Otros números de identificación del estudio
- NPC-biomarkers1
- HKCTR-1271 (Identificador de registro: Hong Kong Clinical Trials Register)
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