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Clinical Trials/NCT05512195
NCT05512195
Not yet recruiting
Not Applicable

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

Zhongnan Hospital0 sites70 target enrollmentSeptember 1, 2022
ConditionsGlioblastoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glioblastoma
Sponsor
Zhongnan Hospital
Enrollment
70
Primary Endpoint
Overall survival (OS)
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
August 31, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Zhongnan Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Overall survival (OS)

Time Frame: 2 years

Time from the start of treatment to death due to the disease

Secondary Outcomes

  • recurrence-free survival (RFS)(1 year)

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