NCT04747145

Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma

A Phase II Study Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma (PRORADGLIO Study)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-arm, single-center phase 2 study designed to assess the efficacy of pulsed reduced dose-rate radiotherapy in the initial treatment of maximally safely resected glioblastoma. The primary endpoint will be progression-free survival at six months. Patients with pathologically confirmed GBM who are planned for six weeks of adjuvant chemoradiation followed by six to12 months of adjuvant chemotherapy will be screened and enrolled after surgery.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-03
• Primary completion: 2025-03-05
• Completion: 2027-09-01
• First posted: 2021-02-10
• Last updated: 2025-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study