Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05512195 |
| Other study ID # |
ZhongnanH GBM |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
August 31, 2025 |
Study information
| Verified date |
August 2022 |
| Source |
Zhongnan Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
