The NeoGlioma Study

Overview

Información sobre este estudio

This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Age >= 18 years

- Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged
by the Mayo multidisciplinary neuro-oncology team (World Health Organization [WHO]
grade III-IV, including glioblastoma) regardless of IDH and MGMT status

- Planned neurosurgical resection of tumor

- Judged to not be at risk of significant clinical risk (i.e. herniation) with
radiation-induced edema prior to resection

- No prior history of cranial radiotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

- Negative pregnancy test done =< 14 days prior to registration, for women of
childbearing potential only

- Ability to complete questionnaire(s) by themselves or with assistance

- Provide written informed consent

- Planning to receive adjuvant radiotherapy at enrolling institution

- Willing to provide tissue and/or blood samples for correlative research purposes

- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to
registration)

- Platelet count >= 80,000/mm^3 (80 x 10^9/L) (obtained =< 14 days prior to
registration)

- Hemoglobin (Hgb) >= 9 g/dL (=< 14 days prior to registration)

Exclusion Criteria:

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception

- Unwillingness to participate in study

- Investigator discretion that enrollment on the study would pose undo harm or risk to
the patient

- Non-MRI compatible implanted medical device

- Use of systemic anti-cancer therapy within the previous 3 months

- Medical contraindication to craniotomy and tumor resection

- Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor

- Note: Patients with a history of grade I-II glioma are eligible if they have only
received surgery as treatment and now there is concern for transformation to
grade III-IV tumor

- Primary spinal cord glioma or primary brainstem glioma

- Residual tumor of excessive volume or eloquent location per investigator discretion

- Patients who are unwilling or unable to comply with study procedures

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/20/2024. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Daniel Trifiletti, M.D.

Abierto para la inscripción

Contact information:

Jacquelyn Gardner M.B.A.

Gardner.Jacquelyn@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20519962

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