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

NCT05512195 | Unknown

• 1 other identifier: ZhongnanH GBM
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

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

  2 years

Secondary Outcomes (1)

• recurrence-free survival (RFS)

  1 year

Study Arms (1)

New delineation approach （NDA）group

EXPERIMENTAL

use a new method for clinical target volume delineation by referencing the nerve fiber bundles

Radiation: New delineation approach

Interventions

New delineation approach RADIATION

New delineation approach

New delineation approach （NDA）group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongnan Hospital: lead

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 23, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: August 31, 2025
• Last Updated: August 23, 2022

Record last verified: 2022-08