Advanced Imaging-Guided Standard Versus Dose-Intensified Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma, SAGA 2.0 Trial

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

This clinical trial studies how well advanced imaging-guided standard dose versus (vs.) dose-intensified radiation therapy (RT) and dose-intensified accelerated RT works in treating patients with newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. During dose-intensified RT, a higher dose than normal of radiation therapy is delivered over 6 weeks. During dose-intensified accelerated RT, the higher dose of radiation therapy is delivered over a shorter amount of time (2 weeks) than normal (6 weeks). Patients also undergo an advanced brain imaging positron emission tomography (PET)/computed tomography (CT) scan (using a radioactive drug called either FET or FDOPA) prior to RT to that may help doctors better plan the treatment. Dose-intensified and dose-intensified accelerated radiation therapy may be effective in treating patients with newly diagnosed glioblastoma. Giving dose-intensified RT or dose-intensified accelerated RT guided by advanced imaging may work better than standard dose RT in treating patients with newly diagnosed glioblastoma.

A vizsgálat 4 csoportja

• Arm A (dose-intensified radiation therapy)A vizsgált kezelés

  Patients undergo thirty treatment fractions of dose-intensified proton or photon radiation therapy QD (Monday-Friday) over 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI and blood sample collection throughout the study.

  Kezelés: Biospecimen Collection, Computed Tomography, F-18 Fluoroethyltyrosine, Fluorodopa F 18, Magnetic Resonance Imaging, Dose-intensified Photon Beam Radiation Therapy, Positron Emission Tomography, Proton Beam Radiation Therapy, Questionnaire Administration és Temozolomide

• Arm B (standard radiation therapy)Már használt kezelés, összehasonlításként

  Patients undergo thirty treatment fractions of standard proton or photon radiation therapy QD (Monday-Friday) over 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI and blood sample collection throughout the study.

  Kezelés: Biospecimen Collection, Computed Tomography, F-18 Fluoroethyltyrosine, Fluorodopa F 18, Magnetic Resonance Imaging, Standard Photon Beam Radiation Therapy, Positron Emission Tomography, Proton Beam Radiation Therapy, Questionnaire Administration és Temozolomide

• Arm C (dose-intensified accelerated radiation therapy)A vizsgált kezelés

  Patients undergo ten treatment fractions of dose-intensified accelerated proton or photon radiation therapy QD (Monday-Friday) over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI throughout the study.

  Kezelés: Computed Tomography, F-18 Fluoroethyltyrosine, Fluorodopa F 18, Magnetic Resonance Imaging, Dose-intensified Accelerated Photon Beam Radiation Therapy, Positron Emission Tomography, Proton Beam Radiation Therapy és Temozolomide

• Arm D (accelerated radiation therapy)Már használt kezelés, összehasonlításként

  Patients undergo ten treatment fractions of accelerated proton or photon radiation therapy QD (Monday-Friday) over 2 weeks in the absence of unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI throughout the study.

  Kezelés: Computed Tomography, F-18 Fluoroethyltyrosine, Fluorodopa F 18, Magnetic Resonance Imaging, Accelerated Photon Beam Radiation Therapy, Positron Emission Tomography, Proton Beam Radiation Therapy és Temozolomide