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Trial Title:
Safety and Efficacy of a New Approach to Delineating Clinical Target Volume of Glioblastoma
NCT ID:
NCT05512195
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Conditions: Keywords:
Radiotherapy, clinical target volume, Glioblastoma multiforme (GBM), radiation volume, the white matter tracts.
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
New delineation approach
Description:
New delineation approach
Arm group label:
New delineation approach （NDA）group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
September 1, 2022
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512195
