NCT06201351

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Jan 2024Sep 2026

First Submitted

Initial submission to the registry

November 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

January 11, 2024

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

November 28, 2023

Last Update Submit

January 10, 2024

Conditions

Keywords

adaptive radiotherapyhigh-grade gliomaMRI image

Outcome Measures

Primary Outcomes (3)

  • Homogeneity index

    HI: Homogeneity index. Dosimetric change

    up to 2 weeks

  • conformity index

    CI: conformity index. Dosimetric change

    up to 2 weeks

  • Anatomic change

    Dmax Volume

    up to 2 weeks

Secondary Outcomes (1)

  • progression-free survival (PFS)

    assessed up to 12 months

Study Arms (1)

Adaptive radiotherapy group

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

Device: adaptive radiotherapy

Interventions

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

Also known as: ART
Adaptive radiotherapy group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Ping Ai, MD

CONTACT

Shuangshuang He

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 28, 2023

First Posted

January 11, 2024

Study Start

January 1, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

January 11, 2024

Record last verified: 2023-12

Locations