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

January 10, 2024 updated by: Ping Ai, West China Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital
        • Contact:
          • Biomedical Ethics Review Committee, West China Hospital
          • Phone Number: 8685423237
          • Email: aip2023@163.com
        • Principal Investigator:
          • Ping Ai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with high-grade glioma confirmed by pathology in our hospital and treated with standard STUPP regimen.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adaptive radiotherapy group
MRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy.
Device: adaptive radiotherapy
MRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy.
Other Names:
  • ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homogeneity index
Time Frame: up to 2 weeks
HI: Homogeneity index. Dosimetric change
up to 2 weeks
conformity index
Time Frame: up to 2 weeks
CI: conformity index. Dosimetric change
up to 2 weeks
Anatomic change
Time Frame: up to 2 weeks
Dmax Volume
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: assessed up to 12 months
progression-free survival
assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trial No. 1460, 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on High-grade Glioma

Clinical Trials on adaptive radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe