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Simultaneous Integrated Boost in Malignant Glioma Patients Treated With Chemoradiation

Primary Purpose

Glioblastoma Multiforme, Chemoradiation

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Simultaneous integrated boost
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma, Chemoradiation, Simultaneous integrated boost

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taichung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Simultaneous integrated boost

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression Free survival rate
Actual one-year progression-free survival rate

Secondary Outcome Measures

Surgical extent
No contrast-enhanced area: gross total resection; Any contrast-enhanced area: residual tumor

Full Information

First Posted
July 19, 2017
Last Updated
July 20, 2017
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03225300
Brief Title
Simultaneous Integrated Boost in Malignant Glioma Patients Treated With Chemoradiation
Official Title
Evaluation the Prognostic Significance of High Radiation Dose in Malignant Glioma Patients Treated With Chemoradiation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2005 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme, Chemoradiation
Keywords
Glioblastoma, Chemoradiation, Simultaneous integrated boost

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospectively single arm in single institution.
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simultaneous integrated boost
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Simultaneous integrated boost
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free survival rate
Description
Actual one-year progression-free survival rate
Time Frame
at the end of first year
Secondary Outcome Measure Information:
Title
Surgical extent
Description
No contrast-enhanced area: gross total resection; Any contrast-enhanced area: residual tumor
Time Frame
CT within 72 hours and MRI at 4th week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weir Chiang You, M.D. Ph.D.
Organizational Affiliation
Dempartment of Radiation Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weir Chiang You, M.D. PhD
Phone
886-4-23592525
Ext
5602
Email
bigjohnyou@vghtc.gov.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
20364023
Citation
Bauchet L, Mathieu-Daude H, Fabbro-Peray P, Rigau V, Fabbro M, Chinot O, Pallusseau L, Carnin C, Laine K, Schlama A, Thiebaut A, Patru MC, Bauchet F, Lionnet M, Wager M, Faillot T, Taillandier L, Figarella-Branger D, Capelle L, Loiseau H, Frappaz D, Campello C, Kerr C, Duffau H, Reme-Saumon M, Tretarre B, Daures JP, Henin D, Labrousse F, Menei P, Honnorat J; Societe Francaise de Neurochirurgie (SFNC); Club de Neuro-Oncologie of the Societe Francaise de Neurochirurgie (CNO-SFNC); Societe Francaise de Neuropathologie (SFNP); Association des Neuro-Oncologues d'Expression Francaise (ANOCEF). Oncological patterns of care and outcome for 952 patients with newly diagnosed glioblastoma in 2004. Neuro Oncol. 2010 Jul;12(7):725-35. doi: 10.1093/neuonc/noq030. Epub 2010 Apr 2.
Results Reference
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PubMed Identifier
21236604
Citation
Monjazeb AM, Ayala D, Jensen C, Case LD, Bourland JD, Ellis TL, McMullen KP, Chan MD, Tatter SB, Lesser GJ, Shaw EG. A phase I dose escalation study of hypofractionated IMRT field-in-field boost for newly diagnosed glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):743-8. doi: 10.1016/j.ijrobp.2010.10.018. Epub 2011 Jan 13.
Results Reference
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Simultaneous Integrated Boost in Malignant Glioma Patients Treated With Chemoradiation

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