Safety and Efficacy of a New Approach to Delineating Clinical Target Volume of Glioblastoma (GBM)

Safety and Efficacy of a New Approach to Delineating Clinical Target Volume by Referencing the Nerve Fiber Bundles for Radiotherapy of Glioblastoma

Radiotherapy (RT) is one of the most important local treatments besides surgery, but currently, no consensus has been made regarding the optimal radiation volume for high grade gliomas. The most main growth characteristics of glioblastoma is infiltrative growth through the white matter tracts, regions along the white matter tracts especially at the direction of the main fiber bundles would have a higher risk of microscopic tumor cell dissemination. However, in current practice, recommends for the CTV definition is adding a 2 cm symmetrical margin to GTV or peritumoral edema in all directions, which hardly account for the growth characteristics of gliomas that are known from histopathological findings.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Radiation: New delineation approach

Detailed Description

Patients with glioblastoma were recruited for this study based on the following eligibility criteria: Age between 18 and 70, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed glioblastoma, no cerebrospinal fluid and distant metastatic disease. All patients had adequate hematologic, hepatic, and renal function. Patients younger than 18 years; patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities were excluded.

Eligible patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）, followed by 6 additional cycles of TMZ. (150 mg/m2 for the first cycle and 200 mg/m2 for the 2-6th cycles, on days 1-5, every 4 weeks) .

The investigators established a detailed protocol for target delineation of the CTV based on brain anatomy, white mater fiber tracts distribution and the growth patterns of tumor. Briefly, along the directions of the main nerve fiber bundles ，the CTV is defined as peritumoral edema plus 1cm. while in other directions, the CTV is defined as GTV plus 2cm and should be adjusted to anatomical borders such as the skull (0 mm, using bone window), ventricles (5 mm), falx (0 mm), tentorium cerebelli (0 mm), visual pathway/optic chiasm and brainstem (each 0 mm) and modified to include all regions of abnormal T2/FLAIR MRI signal. Deep brain white matter is the focus for RT target contour, regions of normal uninvolved gray matter should be modified to be protected.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18-70 years
• performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
• histologically confirmed glioblastoma
• no cerebrospinal fluid and distant metastatic disease
• All patients had adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

• younger than 18 years;
• patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New delineation approach （NDA）group; use a new method for clinical target volume delineation by referencing the nerve fiber bundles	Radiation: New delineation approach; New delineation approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Time from the start of treatment to death due to the disease	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence-free survival (RFS)	Time from the start of treatment to recurrence	1 year

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Radiotherapy, clinical target volume, Glioblastoma multiforme (GBM), radiation volume, the white matter tracts.
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: ZhongnanH GBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No