Clinical trial NCT03225300: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Glioblastoma Multiforme
Chemoradiation
Keywords: Glioblastoma
Chemoradiation
Simultaneous integrated boost
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospectively single arm in single institution.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression Free survival rate
timeFrame: at the end of first year
Secondary outcomes:
measure: Surgical extent
timeFrame: CT within 72 hours and MRI at 4th week after surgery
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Dempartment of Radiation Oncology
name: Weir Chiang You, M.D. Ph.D.
role: STUDY_CHAIR
References:
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.
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.