High-grade GliomaNCT06201351
Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction MRI
An observational study of High-grade Glioma, run by West China Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High-grade Glioma
- What is being tested?
- adaptive radiotherapy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high-grade glioma confirmed by pathology in our hospital and treated with standard STUPP regimen.
Who may be able to join
- Age ≥18 years old;
- High-grade glioma was confirmed by pathology after surgery;
- ECOG score 0-2 points;
- Receiving the standard STUPP regimen (i.e. 6 weeks of temozolomide concurrent chemoradiotherapy +6 cycles of temozolomide adjuvant chemotherapy);
- Baseline data available.
Who cannot join
- The pathological diagnosis is not clear;
- No synchronous chemotherapy/adjuvant chemotherapy \< 6 cycles;
- There are other malignant tumors;
- Previously radiotherapy to the head;
- Interruption of radiotherapy for more than 5 days;
- Failure to collect baseline data.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital
Chengdu, Sichuan, 610041
Biomedical Ethics Review Committee, West China Hospital, 8685423237, aip2023@163.com
Ping Ai, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- High-grade Glioma
- Being tested
- adaptive radiotherapy
- Keywords
- adaptive radiotherapy, high-grade glioma, MRI image
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adaptive radiotherapyDevice
Also called ART
MRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive radiotherapy group | MRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy. Receives: Device: adaptive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homogeneity index
HI: Homogeneity index. Dosimetric change
Measured: up to 2 weeks
conformity index
CI: conformity index. Dosimetric change
Measured: up to 2 weeks
Anatomic change
Dmax Volume
Measured: up to 2 weeks
Secondary outcomes (1)
progression-free survival (PFS)
progression-free survival
Measured: assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-grade GliomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Ai, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201351
- Sponsor's protocol ID
- Trial No. 1460, 2023
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
He S, Yu H, Yang Y, Mao Q, Wang X, Zeng Y, Wang F, Liu M, Li Y, Gao K, Peng X, Liu Y, Ai P. Study of Adaptive Radiotherapy for High-Grade Glioma Based on Interfraction MRI. Cancer Med. 2026 Sep;15(9):e72225. doi: 10.1002/cam4.72225.
PubMed 42675793
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT06201351
- Acronym / sponsor ID
- Trial No. 1460, 2023
- Conditions
- High-grade Glioma
- Keywords
- adaptive radiotherapy, high-grade glioma, MRI image
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive radiotherapy group | – | Device: adaptive radiotherapyMRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high-grade glioma confirmed by pathology in our hospital and treated with standard STUPP regimen.
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- High-grade glioma was confirmed by pathology after surgery;
- ECOG score 0-2 points;
- Receiving the standard STUPP regimen (i.e. 6 weeks of temozolomide concurrent chemoradiotherapy +6 cycles of temozolomide adjuvant chemotherapy);
- Baseline data available.
Key exclusion criteria (6 listed)
- The pathological diagnosis is not clear;
- No synchronous chemotherapy/adjuvant chemotherapy \< 6 cycles;
- There are other malignant tumors;
- Previously radiotherapy to the head;
- Interruption of radiotherapy for more than 5 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adaptive radiotherapyAlso: ARTMRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy. | Device | Adaptive radiotherapy group |
Primary outcome
Homogeneity index
Time frame: up to 2 weeks
HI: Homogeneity index. Dosimetric change
conformity index
Time frame: up to 2 weeks
CI: conformity index. Dosimetric change
Anatomic change
Time frame: up to 2 weeks
Dmax Volume
1 secondary outcome
progression-free survival (PFS)
Time frame: assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 42675793He S, Yu H, Yang Y, Mao Q, Wang X, Zeng Y, Wang F, Liu M, Li Y, Gao K, Peng X, Liu Y, Ai P. Study of Adaptive Radiotherapy for High-Grade Glioma Based on Interfraction MRI. Cancer Med. 2026 Sep;15(9):e72225. doi: 10.1002/cam4.72225.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-grade Glioma, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Ai, MD (18980602055, aip2023@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homogeneity index (time frame: up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.