Simultaneous Integrated Boost in Malignant Glioma Patients Treated With Chemoradiation

NCT ID: NCT03225300

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Glioblastoma Multiforme Chemoradiation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospectively single arm in single institution.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Simultaneous integrated boost

Intervention Type RADIATION

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.

Interventions

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Simultaneous integrated boost

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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weir Chiang You, M.D. Ph.D.

Role: STUDY_CHAIR

Dempartment of Radiation Oncology

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Weir Chiang You, M.D. PhD

Role: primary

886-4-23592525 ext. 5602

References

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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.

Reference Type BACKGROUND
PMID: 20364023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21236604 (View on PubMed)

Other Identifiers

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CE17194B

Identifier Type: -

Identifier Source: org_study_id

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