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

High-grade Glioma Clinical Trial

Official title:

Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction Magnetic Resonance Imaging (MRI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06201351
• Other study ID #: Trial No. 1460, 2023
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: December 2023
• Source: West China Hospital
• Contact: Ping Ai, MD
• Phone: 18980602055
• Email: aip2023[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• High-grade Glioma

Intervention

Device:
• adaptive radiotherapy
MRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homogeneity index	HI: Homogeneity index. Dosimetric change	up to 2 weeks
Primary	conformity index	CI: conformity index. Dosimetric change	up to 2 weeks
Primary	Anatomic change	Dmax Volume	up to 2 weeks
Secondary	progression-free survival (PFS)	progression-free survival	assessed up to 12 months