Un estudio que compara la radioterapia personalizada con la radioterapia estándar en personas con cáncer de garganta positivo para el VPH
Ensayo de fase III, aleatorizado y doble ciego de radiación reducida en cáncer de orofaringe con VPH positivo seleccionado por FMISO de buen riesgo versus radiación estándar de atención en cáncer de orofaringe positivo para VPH no seleccionado
The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following:
- Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy
- How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Nancy Lee, MD
- Número de teléfono: 212-639-3341
- Correo electrónico: leen2@mskcc.org
Copia de seguridad de contactos de estudio
- Nombre: Nadeem Riaz, MD
- Número de teléfono: 646-888-3495
Ubicaciones de estudio
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06102
- Reclutamiento
- Hartford Healthcare (Data Collection Only)
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Contacto:
- Charles Rutter, MD
- Número de teléfono: 860-972-2803
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Florida
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Miami, Florida, Estados Unidos, 33143
- Reclutamiento
- Baptist Alliance MCI (Data Collection Only)
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Contacto:
- Noah Kalman, MD
- Número de teléfono: 786-596-2000
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New Jersey
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Basking Ridge, New Jersey, Estados Unidos, 07920
- Reclutamiento
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Contacto:
- Nancy Lee, MD
- Número de teléfono: 212-639-3341
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Middletown, New Jersey, Estados Unidos, 07748
- Reclutamiento
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Contacto:
- Nancy Lee, MD
- Número de teléfono: 212-639-3341
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Montvale, New Jersey, Estados Unidos, 07645
- Reclutamiento
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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Contacto:
- Nancy Lee, MD
- Número de teléfono: 212-639-3341
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New York
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Commack, New York, Estados Unidos, 11725
- Reclutamiento
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
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Contacto:
- Nancy Lee, MD
- Número de teléfono: 212-639-3341
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Harrison, New York, Estados Unidos, 10604
- Reclutamiento
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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Contacto:
- Nancy Lee, MD
- Número de teléfono: 212-639-3341
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New York, New York, Estados Unidos, 10065
- Reclutamiento
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Contacto:
- Nancy Lee, MD
- Número de teléfono: 212-639-3341
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Uniondale, New York, Estados Unidos, 11553
- Reclutamiento
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Contacto:
- Nancy Lee, MD
- Número de teléfono: 212-639-3341
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) or squamous cell carcinoma with an unknown primary. Surgical removal of primary site is allowed.
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Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization (RNAscope® 2.5 HD Reagent kit (Advanced Cell Diagnostics, Inc, Hayward, CA). Any CLIA certified testing method can be used.
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Clinical stage Tx-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
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ECOG Performance Status of 0-1 or KPS >/=70
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Age ≥ 18
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Adequate hematologic function within 30 days prior to registration, defined as follows:
- White Blood Count (WBC) ≥ 2 K/mcL
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
- Platelets ≥ 100,000 cells/mm^3
- Hemoglobin ≥ 10.0 g/dl
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Adequate renal function within 30 days prior to registration, defined as follows:
o Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)
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Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
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The patient must provide study-specific informed consent prior to study entry
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Optional section of the protocol: Patients must be able to undergo MRI scans, i.e. not claustrophobic
Exclusion Criteria:
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Patients with prior head and neck radiation therapy where there is >30% overlap with the current head and neck radiation fields. Exceptions can be made if determined by the PI/Co-PI that the patient can proceed with protocol activities
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Patients whose tumors are borderline T4 based on anterior tumor extension to the extrinsic muscles of the tongue
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Patients with simultaneous primary cancers outside of the oropharynx
o Note: Exceptions can be made for patients with simultaneous primaries outside the oropharynx if determined by the PI/Co-PI the patient can proceed with protocol activities
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Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater
o Note: Exceptions can be made for patients with prior malignancies outside the oropharynx if determined by the PI/Co-PI the patient can proceed with protocol activities.
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Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
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No particle therapy
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Patients who are deemed non-compliant to all the protocol related activities
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Contraindications to receive either cisplatin or the combination of carboplatin/5-fluorouracil at the prescribed doses.
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Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
- Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Personalized Chemoradiation Therapy
Patient without evidence of hypoxia will receive 30Gy in 2Gy per fraction. Concurrent chemotherapy will be given as per guidelines. After completion of chemotherapy and radiation therapy, a 4 month (+/- 4 weeks) posttreatment standard FDG PET/CT scan will be performed and if there is persistent disease, standard neck dissection will be performed. Further standard of care will be given pending pathologic findings.1. Hypoxia negative: The entire target volume which includes GTV and CTV will receive 30Gy in 2 Gy per fraction over 15 days (PTV30). 2. Hypoxia positive (same as the standard of care): The CTV will receive 50Gy in 2Gy per fraction over 25 days. This is name PTV50 and will receive 50Gy in 2Gy per fraction over 25 days. The GTV will receive an additional boost of 20Gy in 2 Gy per fraction so that the total PTV70 dose is 70Gy. |
Patients will undergo 18F-FMISO scan (only 1 injection) that occurs at week two of radiation treatment, typically day 10 but a window of 8-10 radiation treatment days* after start of radiation is allowed. 30 Gy or 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU) 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU) EQ-5D-5L (5 questions); 2. MDADI-HN (total of 20 questions); 3. COST-FACIT (total of 12 questions). |
|
Comparador activo: Standard Chemoradiation Therapy
Patient will receive 70Gy in 2Gy per fraction regardless of hypoxia status. Concurrent chemotherapy will be given as per guidelines. After completion of chemotherapy and radiation therapy, a 4 month (+/- 4 weeks) posttreatment standard FDG PET/CT scan will be performed and if there is persistent disease, standard neck dissection will be performed. Further standard of care will be given pending pathologic findings. |
Patients will undergo 18F-FMISO scan (only 1 injection) that occurs at week two of radiation treatment, typically day 10 but a window of 8-10 radiation treatment days* after start of radiation is allowed. 30 Gy or 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU) 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU) EQ-5D-5L (5 questions); 2. MDADI-HN (total of 20 questions); 3. COST-FACIT (total of 12 questions). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
overall survival
Periodo de tiempo: 2 years
|
The measurement of survival will be evaluated as a time from randomization to events endpoint (i.e., death due to any cause) so that censored data are allowed. To assess the overall survival rate, Kaplan-Meier estimates will be calculated and reported. |
2 years
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Nancy Lee, MD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 24-200
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
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.
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