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NCT Number: NCT06201351

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Location contact

Biomedical Ethics Review Committee, West China Hospital

CONTACT

[email protected]

8685423237

Ping Ai, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

adaptive radiotherapy

Device

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

Other names: ART

Primary outcomes

  1. Homogeneity index

    Time frame: up to 2 weeks

    HI: Homogeneity index. Dosimetric change

  2. conformity index

    Time frame: up to 2 weeks

    CI: conformity index. Dosimetric change

  3. Anatomic change

    Time frame: up to 2 weeks

    Dmax Volume

Secondary outcomes

  1. progression-free survival (PFS)

    Time frame: assessed up to 12 months

    progression-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Ai, MD

CONTACT

[email protected]

18980602055

Shuangshuang He

CONTACT

[email protected]

18708178816

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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