Simultaneous Integrated Boost in Malignant Glioma Patients Treated With Chemoradiation

Not Applicable

• Conditions: Glioblastoma Multiforme; Chemoradiation
• Interventions: Radiation: Simultaneous integrated boost

• Registration Number: NCT03225300
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

Simultaneous integrated boost (SIB), a field-in-field escalation technique, has been introduced to deliver higher radiation dose to the certain part of target with the same fractionation scheme. The aim of this study was to investigate the value of chemoradiation (CCRT) using SIB in glioblastoma and the correlation with surgical extent.

Detailed Description

The SIB technique provides the higher radiobiological effect with the same fractionation scheme, i.e. 69 Gy over 6 weeks, which might increase the loco-regional control. Besides, the co-registration with magnetic resonance imaging (MRI) strengthens the precision of target delineation as well as higher possibility to spare adjacent normal brain tissue.

In this protocol, the newly diagnosed, primary glioblastoma patients received SIB 69 Gy/30 fractions to preoperative tumor bed and surgical cavity, while 60 Gy/30 fractions were covering preoperatively edematous area. To determine the status of surgical extent, postoperative CT scan and MRI was acquired within 72 hours and at 4th week after surgery. During the period of chemoradiation, acute neurotoxicity and hematological toxicity was assessed as well.

Study Timeline

• Study Start: 2005-01-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-20
• Last Update Submitted: 2017-07-20
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• age 18 years or above
• newly diagnosed, tissue-proven glioblastoma
• pre-radiotherapy Karnofsky performance score (KPS) ≧60.

Exclusion Criteria

• any previous history of chemotherapy or radiotherapy
• receiver of any investigating agents
• recurrent GBM
• any second malignancies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simultaneous integrated boost	Simultaneous integrated boost	In this protocol, the newly diagnosed, primary glioblastoma patients receive SIB 69 Gy/30 fractions to preoperative tumor bed and surgical cavity, while 60 Gy/30 fractions were covering preoperatively edematous area. PTV is 5 mm.

Primary Outcome Measures

Name	Time	Method
Progression Free survival rate	at the end of first year	Actual one-year progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
Surgical extent	CT within 72 hours and MRI at 4th week after surgery	No contrast-enhanced area: gross total resection; Any contrast-enhanced area: residual tumor

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan