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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05512195
Acronym
GBM
Enrollment
70
Registered
2022-08-23
Start date
2022-09-01
Completion date
2025-08-31
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Keywords

Radiotherapy, clinical target volume, Glioblastoma multiforme (GBM), radiation volume, the white matter tracts.

Brief summary

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.

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.

Interventions

RADIATIONNew delineation approach

New delineation approach

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival (OS)2 yearsTime from the start of treatment to death due to the disease

Secondary

MeasureTime frameDescription
recurrence-free survival (RFS)1 yearTime from the start of treatment to recurrence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026