Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patient… (NCT04574856) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma
United States30 participantsStarted 2020-11-04
Plain-language summary
This study will investigate whether or not intensified radiation therapy adapted during the radiation treatment course to high-risk, treatment-resistant tumor regions will improve overall survival in patients with newly diagnosed glioblastoma (GBM) compared to conventional chemoradiotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Newly diagnosed, histologically-confirmed supratentorial WHO grade IV gliomas including glioblastoma (all variants) and gliosarcoma. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
* Karnofsky performance status \>=70
* Minimal life expectancy of 12 weeks
* Adequate bone marrow reserve (Hemoglobin ≥ 10 g/dL, absolute neutrophils ≥ 1500/mm3, platelet count ≥ 100,000/mm3), acceptable liver function (total bilirubin ≤ 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome), and ALT/AST ≤ 5 x ULN) and renal function (serum creatinine ≤ 2.0 mg/dL) within 14 day prior to registration. Eligibility level for hemoglobin may be reached by transfusion.
* Maximal contiguous diameter of tumor based on high b-value diffusion MRI and DCE perfusion MRI ≤5 cm
* Patients must be registered within 6 weeks of most recent resection
* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment and study participation.
Exclusion Criteria:
* Recurrent glioma, or tumor involving the brainstem or cerebellum
* Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not pe…