Simultaneous Integrated Boost in Malignant Glioma Patients Treated With Chemoradiation

Glioblastoma Multiforme Clinical Trial

Official title:

Evaluation the Prognostic Significance of High Radiation Dose in Malignant Glioma Patients Treated With Chemoradiation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03225300
• Other study ID #: CE17194B
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2017
• Last updated: July 20, 2017
• Start date: January 1, 2005
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2017
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemoradiation
• Glioblastoma
• Glioblastoma Multiforme
• Glioma

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Bauchet L, Mathieu-Daudé H, Fabbro-Peray P, Rigau V, Fabbro M, Chinot O, Pallusseau L, Carnin C, Lainé 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, Trétarre B, Daures JP, Henin D, Labrousse F, Menei P, Honnorat J; Société Française de Neurochirurgie (SFNC); Club de Neuro-Oncologie of the Société Française de Neurochirurgie (CNO-SFNC); Société Française de Neuropathologie (SFNP); Association des Neuro-Oncologues d'Expression Française (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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free survival rate	Actual one-year progression-free survival rate	at the end of first year
Secondary	Surgical extent	No contrast-enhanced area: gross total resection; Any contrast-enhanced area: residual tumor	CT within 72 hours and MRI at 4th week after surgery