Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction MRI

Not yet recruiting

• Conditions: High-grade Glioma

• Registration Number: NCT06201351
• Lead Sponsor: West China Hospital

Brief Summary

The changes of target and organs at risk in patients with high-grade glioma during concurrent chemoradiotherapy were evaluated by MRI image between radiotherapy fractions.

Detailed Description

To prospectively evaluate the changes of target organs and risk organs in patients with high-grade glioma during concurrent chemoradiotherapy.The related factors causing this change are discussed.The relationship between changes and patient survival was analyzed.A predictive model was established to provide individualized adaptive radiotherapy for patients.

Study Timeline

• Study First Submitted: 2023-11-28
• Status Verified: 2023-12
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Primary Completion: 2025-12-01
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age ≥18 years old;
2. High-grade glioma was confirmed by pathology after surgery;
3. ECOG score 0-2 points;
4. Receiving the standard STUPP regimen (i.e. 6 weeks of temozolomide concurrent chemoradiotherapy +6 cycles of temozolomide adjuvant chemotherapy);
5. Baseline data available.

Exclusion Criteria

1. The pathological diagnosis is not clear;
2. No synchronous chemotherapy/adjuvant chemotherapy < 6 cycles;
3. There are other malignant tumors;
4. Previously radiotherapy to the head;
5. Interruption of radiotherapy for more than 5 days;
6. Failure to collect baseline data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
conformity index	up to 2 weeks	CI: conformity index. Dosimetric change
Homogeneity index	up to 2 weeks	HI: Homogeneity index. Dosimetric change
Anatomic change	up to 2 weeks	Dmax Volume

Secondary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	assessed up to 12 months	progression-free survival

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China