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Radiocirugía estereotáctica de fracción única en comparación con radiocirugía estereotáctica fraccionada para el tratamiento de la enfermedad cerebral metastásica intacta, ensayo FRACTIONATE

29 de septiembre de 2026 actualizado por: Mayo Clinic

Ensayo de fase IIR de radiocirugía estereotáctica de fracción única (SRS) en comparación con SRS fraccionado (FSRS) para la enfermedad cerebral metastásica intacta (FRACTIONATE)

This phase II trial compares the effect of single fraction stereotactic radiosurgery to fractionated stereotactic radiosurgery for the treatment of patients with cancer that has spread to the brain (metastatic brain disease). Stereotactic radiosurgery (SRS) is a form of radiation therapy that focuses high-power energy on a small area of the body. This trial is being done to determine if single (one) fraction stereotactic radiosurgery is better than fractionated stereotactic radiosurgery or vice versa in controlling tumor and side effects in patients with tumors that have spread to the brain.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVE:

I. To ascertain if the composite endpoint of cumulative treatment failure, defined by time to either local failure or symptomatic radiation brain necrosis of the largest brain metastasis (target lesion), is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS).

SECONDARY OBJECTIVES:

I. To ascertain whether there is improved overall survival in patients who undergo FSRS compared to patients who receive SSRS.

II. To tabulate and descriptively compare the post-treatment adverse events associated with the interventions, including the potential impact of immunotherapy and targeted therapy.

III. To compare rates of radiation necrosis in patients who receive FSRS to patients who receive SSRS.

IV. To evaluate if there is any difference in central nervous system (CNS) failure patterns (e.g. local, distant brain failure) in patients who receive FSRS compared to patients who receive SSRS.

V. To ascertain whether FSRS prolongs time to neurologic death as compared to SRS.

VI. To determine whether there is improved patient reported outcomes (Functional Assessment of Cancer Therapy [FACT]-Brain Symptom Index [FBrSI]-24) including quality of life for patients who receive FSRS compared to patients who receive SSRS.

VII. To evaluate if there is any difference in CNS failure patterns (e.g. local, distant brain failure) and symptomatic radiation necrosis rates in patients who are treated with gamma knife compared to patients who are treated with a linear accelerator platform.

VIII. To determine whether differences in time to local failure, time to necrosis, or their composite endpoint cumulative treatment failure differs between treatment arms (or other patient or treatment factors) when analyzed on a "per lesion" basis rather than the per patient basis utilized for the primary endpoint.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo single fraction SRS. Patients also undergo magnetic resonance imaging (MRI) at screening and during follow up.

ARM B: Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days. Patients also undergo MRI at screening and during follow up.

After completion of study treatment, patients are followed up at 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259
        • Reclutamiento
        • Mayo Clinic in Arizona
        • Contacto:
        • Investigador principal:
          • Sujay A. Vora, MD
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Reclutamiento
        • Mayo Clinic in Florida
        • Contacto:
        • Investigador principal:
          • Jennifer L. Peterson, MD
    • Minnesota
      • Albert Lea, Minnesota, Estados Unidos, 56007
        • Aún no reclutando
        • Mayo Clinic Health System in Albert Lea
        • Contacto:
        • Investigador principal:
          • John Yeakel, MD
        • Contacto:
      • Mankato, Minnesota, Estados Unidos, 56001
        • Reclutamiento
        • Mayo Clinic Health Systems-Mankato
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Jason T. Hayes, MD
      • Rochester, Minnesota, Estados Unidos, 55905
        • Reclutamiento
        • Mayo Clinic in Rochester
        • Investigador principal:
          • Paul D. Brown, M.D.
        • Contacto:
    • Wisconsin
      • Eau Claire, Wisconsin, Estados Unidos, 54701
        • Reclutamiento
        • Mayo Clinic Health System-Eau Claire Clinic
        • Contacto:
        • Investigador principal:
          • Now Bahar Alam, MD
        • Contacto:
      • La Crosse, Wisconsin, Estados Unidos, 54601
        • Reclutamiento
        • Mayo Clinic Health System-Franciscan Healthcare
        • Contacto:
        • Investigador principal:
          • Abigail L. Stockham, MD
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age >= 18 years old

  • Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.)

    • Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible

  • Size of brain metastases

    • At least one intact metastasis (not previously treated with radiosurgery) must measure >= 2.0 cm and =< 4.0 cm in maximal extent on the contrasted pre-treatment magnetic resonance imaging (MRI) brain scan obtained =< 28 days prior to registration
    • If the largest lesion measures >= 2.0 to =< 4.0 cm in maximal extent the patient will be randomized

  • Able to undergo contrast enhanced MRI brain

  • Negative urine or serum pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only

  • Patient is willing and able to provide written informed consent or have a legally Authorized Representative (LAR) who is responsible for the care and well-being of the potential study participant provide consent.

  • Karnofsky performance status (KPS) >= 50

  • Eastern Cooperative Oncology Group (ECOG) performance score of (PS) >= 2

  • Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations

    • Note: Repeat radiosurgery to the same location/lesion is not allowed on this protocol

Exclusion Criteria:

  • Any patient who has received previous whole brain radiation

  • Any brain metastasis that is located in the brainstem measuring >= 2.0 cm in maximal extent

  • Any patient with definitive evidence of leptomeningeal metastasis (LMD)

    • NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion

  • Any patient with an intact brain metastasis measuring > 4.0 cm

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Otro: Arm A (single fraction SRS)

Patients undergo single fraction SRS. Patients also undergo MRI at screening and during follow up.
Procedimiento: Magnetic Resonance Imaging

Undergo MRI

Otros nombres:
  • Resonancia magnética
  • Resonancia magnetica
  • Exploración de imágenes por resonancia magnética
  • SRES
  • Imágenes de RM
  • Imágenes de RMN
  • RMN
  • Imagenes medicas
  • Resonancia Magnética / Resonancia Magnética Nuclear
  • imágenes de resonancia magnética nuclear
  • Imágenes por resonancia magnética (IRM)
  • resonancia magnética nuclear
  • Imágenes por resonancia magnética (procedimiento)
  • Resonancias magnéticas
  • Resonancia magnética estructural
Otro: Questionnaire Administration

Ancillary studies

Radiación: Stereotactic Radiosurgery

Undergo single fraction SRS

Otros nombres:
  • Irradiación estereotáctica de haz externo
  • radioterapia estereotáctica de haz externo
  • Radioterapia estereotáctica
  • radioterapia estereotáxica
  • radiocirugía estereotáxica
  • SRS
Radiación: Stereotactic Radiosurgery

Undergo fractionated SRS

Otros nombres:
  • Irradiación estereotáctica de haz externo
  • radioterapia estereotáctica de haz externo
  • Radioterapia estereotáctica
  • radioterapia estereotáxica
  • radiocirugía estereotáxica
  • SRS
Otro: Arm B (fractionated SRS)

Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days.. Patients also undergo MRI at screening and during follow up.
Procedimiento: Magnetic Resonance Imaging

Undergo MRI

Otros nombres:
  • Resonancia magnética
  • Resonancia magnetica
  • Exploración de imágenes por resonancia magnética
  • SRES
  • Imágenes de RM
  • Imágenes de RMN
  • RMN
  • Imagenes medicas
  • Resonancia Magnética / Resonancia Magnética Nuclear
  • imágenes de resonancia magnética nuclear
  • Imágenes por resonancia magnética (IRM)
  • resonancia magnética nuclear
  • Imágenes por resonancia magnética (procedimiento)
  • Resonancias magnéticas
  • Resonancia magnética estructural
Otro: Questionnaire Administration

Ancillary studies

Radiación: Stereotactic Radiosurgery

Undergo single fraction SRS

Otros nombres:
  • Irradiación estereotáctica de haz externo
  • radioterapia estereotáctica de haz externo
  • Radioterapia estereotáctica
  • radioterapia estereotáxica
  • radiocirugía estereotáxica
  • SRS
Radiación: Stereotactic Radiosurgery

Undergo fractionated SRS

Otros nombres:
  • Irradiación estereotáctica de haz externo
  • radioterapia estereotáctica de haz externo
  • Radioterapia estereotáctica
  • radioterapia estereotáxica
  • radiocirugía estereotáxica
  • SRS

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to local failure or symptomatic radiation brain necrosis of large brain metastasis
Periodo de tiempo: Up to 5 years

Will determine if the composite endpoint of time to local failure or symptomatic radiation brain necrosis of a large brain metastasis [cumulative treatment failure (CTF)] is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS).
Up to 5 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall survival (OS)
Periodo de tiempo: From study entry to death from any cause, assessed up to 5 years

OS will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms. Medians and 95% confidence intervals will be reported.
From study entry to death from any cause, assessed up to 5 years
Incidence of adverse events
Periodo de tiempo: Up to 2 years post radiation therapy

The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Up to 2 years post radiation therapy
Rates of radiation necrosis
Periodo de tiempo: Up to 5 years

Will compare rates of radiation necrosis in patients who receive FSRS to patients who receive SSRS. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Up to 5 years
Central nervous system (CNS) failure patterns (Fractionation)
Periodo de tiempo: Up to 5 years

Will evaluate if there is any difference in CNS failure patterns (e.g. local, distant brain failure) in patients who receive FSRS compared to patients who receive SSRS. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Up to 5 years
Time to neurologic death
Periodo de tiempo: Up to 5 years

Will ascertain whether FSRS prolongs time to neurologic death as compared to SSRS. This will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms. Medians and 95% confidence intervals will be reported.
Up to 5 years
Quality of life (QOL)
Periodo de tiempo: Up to 5 years

Will determine whether there are improved patient reported outcomes (Functional Assessment of Cancer Therapy [FACT]-Brain Symptom Index [FBrSI]-24) including quality of life for patients who receive FSRS compared to patients who receive SSRS. Changes over time in QOL from baseline will be compared between arms using the 2-sample t-test (or Wilcoxon Rank-Sum test for non-normal data). Box-plots will be used to show differences between arms graphically.
Up to 5 years
CNS failure patterns (Gamma Knife)
Periodo de tiempo: Up to 5 years

Will evaluate if there is any difference in CNS failure patterns (e.g. local, distant brain failure) and symptomatic radiation necrosis rates in patients who are treated with Gamma Knife compared to patients who are treated with a linear accelerator platform. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Up to 5 years
Per lesion analysis between treatment arms: time to local failure
Periodo de tiempo: Up to 5 years

Will determine whether differences in time to local failure differs between treatment arms (or other patient or treatment factors) when analyzed on a "per lesion" basis rather than the per patient basis utilized for the primary endpoint. Time-to-event models (Cox and Kaplan- Meier) with sandwich estimators for covariance will be utilized to in treatment comparisons, with model comparisons completed through log-likelihood and Akaike Information Criterion.
Up to 5 years
Per lesion analysis between treatment arms: time to necrosis
Periodo de tiempo: Up to 5 years

Will determine whether differences in time to necrosis differs between treatment arms (or other patient or treatment factors) when analyzed on a "per lesion" basis rather than the per patient basis utilized for the primary endpoint. Time-to-event models (Cox and Kaplan- Meier) with sandwich estimators for covariance will be utilized to in treatment comparisons, with model comparisons completed through log-likelihood and Akaike Information Criterion.
Up to 5 years
Per lesion analysis between treatment arms: endpoint CTF
Periodo de tiempo: Up to 5 years

Will determine whether differences in the composite endpoint CTF differs between treatment arms (or other patient or treatment factors) when analyzed on a "per lesion" basis rather than the per patient basis utilized for the primary endpoint. Time-to-event models (Cox and Kaplan- Meier) with sandwich estimators for covariance will be utilized to in treatment comparisons, with model comparisons completed through log-likelihood and Akaike Information Criterion.
Up to 5 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Mayo Clinic

Investigadores

  • Investigador principal: Paul D. Brown, MD, Mayo Clinic in Rochester

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de marzo de 2022

Finalización primaria (Estimado)

1 de agosto de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

24 de enero de 2022

Publicado por primera vez (Actual)

3 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GMROR2163
  • NCI-2021-14230 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • 21-003768 (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.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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