Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma
NCT04747145 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-08-21
Summary
The primary protocol objective is to assess the impact of substituting pulsed reduced dose radiotherapy (pRDR) for standard radiation therapy in the upfront treatment of glioblastoma (GBM) on disease progression.
Conditions
Interventions
- DEVICE
-
Radiation
60 Gy to be delivered over 30 daily treatments in six weeks. Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.
- DRUG
-
Concurrent Chemotherapy (Temozolomide)
75mg/m\^2 x 42 days (concurrent chemotherapy with radiation). Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.
- DRUG
-
Adjuvant Chemotherapy (Temozolomide)
Starting no sooner than 4 weeks after completion of chemoradiation, 150-200mg/m\^2, days 1-5 of 28-day cycle, for minimum of six cycles and up to 12 cycles.
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Michael Straza, MD, PhD · Medical College of Wisconsin
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-03
- Primary Completion
- 2025-03-05
- Completion
- 2027-09-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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