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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06201351
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

West China Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

High-grade Glioma
Additional Details

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.

Arms & Interventions

Arms

: Adaptive radiotherapy group

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

Interventions

Device: - adaptive radiotherapy

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

Contact a Trial Team

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International Sites

West China Hospital, Chengdu, Sichuan, China

Status

Address

West China Hospital

Chengdu, Sichuan, 610041

Site Contact

Biomedical Ethics Review Committee, West China Hospital

[email protected]

8685423237

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