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HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

NCT04547621 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-14

No results posted yet for this study

Summary

This study aims to evaluate the safety and effectiveness of the combination of 30Gy/5fx HSRT and 20Gy/10fx IMRT adjuvant therapy. The total biological effective dose (BED) of the PTV is 72 Gy in a ratio of alpha/beta ratio of 3, which equals to the conventional 60Gy/30fx treatment. This study can provide evidence for future non-inferiority phase III randomized controlled trials. The abbreviated course of radiotherapy can reduce the treatment time by half, benefit patients, and utilize the health resource.

Conditions

  • Glioma, Malignant

Interventions

DEVICE

Radiation

Intensity-modulated radiotherapy 20Gy/10fx

DEVICE

Radiation

Hypofractionated Stereotactic Radiotherapy 30Gy/5fx

DRUG

Temozolomide

Temozolomide 75 mg/m2 concurrently administered with RT.

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Enmin Wang, MD · CyberKnife Center, Department of Neurosurgery, Huashan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-01-01
Completion
2024-01-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04547621 on ClinicalTrials.gov