MedTrace Logo

A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial

NCT06215495 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-03-15

No results posted yet for this study

Summary

The main question it aims to answer are:

1. whether the new target delineation scheme can improve Progression-free Survival
2. whether it can reduce the incidence of radiation complications in high-grade glioma patients.

Participants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of EORTC(European organisation for research and treatment of cancer) target delineation method.Temozolomide 75 mg / ( m² · d ) will be given to both groups of patients during radiotherapy. After radiotherapy, its dose changes to 150 \~ 200 mg / ( m² · d ) for 5 days and stopped for 23 days as a cycle. There are 6 cycles in total.

Conditions

  • Radiation Toxicity
  • MRI Simulated Positioning
  • High Grade Glioma
  • Progression-free Survival
  • Overall Survival

Interventions

RADIATION

reduced target volume

Delineate residual tumor(GTVp) and tumor bed(GTVtb) on enhanced contrast CT-MRI(T2 fluid attenuated inversion recovery, T2 FLAIR) fusion images. GTVtb and GTVp are expanded by 1cm to CTV\_6000. The clinical target volume\_6000 cGy (CTV\_6000) is partially reduced beyond the skull and midline. According to the CT-MRI(T2 FLAIR) fusion images, the edema area that cannot be seen on contrast-enhanced CT and only can be seen on MRI should be included. If CTV\_6000 includes thalamus, basal ganglia, brainstem or motor cortex, dose of these areas will be limited no more than 54Gy

RADIATION

EORTC (European organisation for research and treatment of cancer) target volume

delineate according to EORTC guideline

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Yujing Tan, Doctor · +8613560347303

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-18
Primary Completion
2027-05-28
Completion
2027-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06215495 on ClinicalTrials.gov