Adding Spatially Fractionated Radiation Therapy to Standard Palliative Radiation for Improving Disease-Related Symptoms in Patients With Unresectable Solid Tumors
Multicenter, Randomized Phase II Trial on Palliative Radiation With or Without Spatially Fractionated Radiotherapy Boost for Unresectable Bulky Malignancies
This clinical trial evaluates whether adding spatially fractionated radiation therapy (SFRT) to standard palliative external beam radiation therapy (EBRT) improves disease-related symptoms in patients with solid tumors that cannot be removed by surgery (unresectable). SFRT, originally termed GRID therapy, is a radiation therapy technique designed to deliver a highly uneven dose of radiation to a tumor. This is achieved by using a grid-like pattern, where isolated regions receive high doses, while the spaces between experience significantly lower doses. This method allows for a greater total dose to be delivered to the tumor while potentially reducing damage to surrounding healthy tissues. EBRT is a type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Adding SFRT to standard palliative EBRT may improve disease-related symptoms such as pain, difficulty breathing, bleeding, or difficulty swallowing in patients with unresectable solid tumors.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Clinical Trials Referral Office
- Número de teléfono: 855-776-0015
- Correo electrónico: mayocliniccancerstudies@mayo.edu
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Reclutamiento
- Mayo Clinic in Arizona
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Contacto:
- Clinical Trials Referral Office
- Número de teléfono: 855-776-0015
- Correo electrónico: mayocliniccancerstudies@mayo.edu
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Investigador principal:
- Diego A. Santos Toesca, MD
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Reclutamiento
- Mayo Clinic in Rochester
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Contacto:
- Clinical Trials Referral Office
- Número de teléfono: 855-776-0015
- Correo electrónico: mayocliniccancerstudies@mayo.edu
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Investigador principal:
- Meng X. Welliver, MD, PhD
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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 proven primary or metastatic solid malignant tumors from any histologic subtype
- Measurable primary or metastatic bulky tumor defined as tumor > 5 cm in largest dimension not eligible for surgical resection or not an ideal candidate for alternative local therapies, e.g., cryoablation, etc.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3 assessed within 30 days of enrollment
- Estimated life expectancy > 3 months, as judged by treating clinician
- Patients must sign Institutional Review Board (IRB) approved study specific informed consent
- Patients must complete all required pre-entry tests within the specified time limits
- Patients must be able to start treatment (radiation) within 60 days of study registration
- Patients must be at least 15 years old
- A minimum most prominent symptom intensity score reported by the patient of >= 5 on an 11-point symptom intensity scale (item 4.3.2), clearly related to the target lesion, within one the following: pain, dyspnea, hemorrhage, or dysphagia
Exclusion Criteria:
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Prior RT to the current target site < 3 months from randomization
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Intracranial invasion by the proposed tumor target or tumor target intertwined with bowel loops
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Concurrent systemic therapy (e.g., chemotherapy, immunotherapy) during RT delivery will not be an exclusion condition
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Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed), for patients whose target tumor is in the pelvis
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Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted for this study
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History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
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On a transplant list
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Any of the following are excluded because this study involves ionizing radiation:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ adequate birth control measures will be asked to stay on adequate forms of birth control until study intervention (therapy) is finished
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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Experimental: Group I (SFRT, EBRT)
Patients undergo a single fraction of SFRT. Starting 1-3 days after SFRT, patients undergo standard palliative EBRT in a dose regimen determined by the treating physician. |
Ancillary studies Ancillary studies Undergo standard palliative EBRT
Otros nombres:
Undergo SFRT
Otros nombres:
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Comparador activo: Group II (EBRT)
Patients undergo standard palliative EBRT in a dose regimen determined by the treating physician. |
Ancillary studies Ancillary studies Undergo standard palliative EBRT
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Response at 1 month - Patient-reported Impression of Change
Periodo de tiempo: Baseline to 1 month follow-up
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Participants rate the most prominent symptom related to the target lesion to be treated on a 7-point scale ranging from -3 (very much worse) to +3 (very much better). Response will be reported as a binary yes/no, defined as a patient reporting that the symptom is moderately better or very much better 1 month after completing treatment. |
Baseline to 1 month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Patient-reported Most Prominent Symptom Intensity
Periodo de tiempo: Baseline to 1 month follow-up
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Participants will record the severity of the most prominent symptom related to the target lesion (e.g., pain, dyspnea, hemorrhage, dysphagia) using an 11-point Likert scale ranging from 0 (none) to 10 (unbearable). A between-group comparison of the magnitude of the severity scores will be made. |
Baseline to 1 month follow-up
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Response at 3 months - Patient-reported Impression of Change
Periodo de tiempo: At 3 month follow-up
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Participants rate the most prominent symptom related to the target lesion to be treated on a 7-point scale ranging from -3 (very much worse) to +3 (very much better). Response will be reported as a binary yes/no, defined as a patient reporting that the symptom is moderately better or very much better 3 months after completing treatment. |
At 3 month follow-up
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Radiographic tumor response
Periodo de tiempo: At 3 month follow-up
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Radiographic tumor response at 3 months post-treatment will be assessed by a modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Radiographic tumor response will be coded as a 1 if the patient meets the complete response (CR) or partial response (PR) modified RECIST criteria and 0 otherwise. Per the modified RECIST criteria, CR will be defined as disappearance of the target lesion, PR will be defined as ≥30% decrease in longest diameter (LD) of target lesion as compared to baseline measurement, Progressive Disease (PD) will be defined as ≥20% increase in LD of target lesion as compared to baseline measurement, and Stable Disease (SD) will be defined as not meeting the criteria for CR, PR, or PD. |
At 3 month follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Diego Augusto Santos Toesca, MD, Mayo Clinic
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GMROA2481
- NCI-2026-06455 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 25-005298 (Otro identificador: Mayo Clinic Institutional Review Board)
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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