Actively Recruiting

Phase Not Applicable
Age: 14Years - 80Years
All Genders
NCT06831773

Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma

Led by Gansu Wuwei Tumor Hospital · Updated on 2025-02-18

23

Participants Needed

1

Research Sites

151 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The objective is to use the advantages of heavy ion physical dosimetry and biology to improve the tumor control rate and long-term survival rate of high-grade glioma, reduce the occurrence of brain tissue radiation damage caused by increasing prescription dose, and provide new treatment suggestions for glioma radiotherapy.

CONDITIONS

Official Title

Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma

Who Can Participate

Age: 14Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 years to 80 years
  • Diagnosis of high-grade glioma based on 2021 WHO CNS tumor classification, including IDH wild-type glioma and IDH mutant Grade II and III gliomas
  • Single or two intracranial lesions covered by the same radiotherapy plan
  • No distant or intraspinal spread or metastasis
  • No tumor ablation or interventional therapy within 4 weeks prior to radiotherapy
  • Surgical wound fully healed
  • Ability to undergo MRI and enhanced CT without metal artifacts
  • No history of other malignant tumors except cured skin cancer and stage 0 cervical cancer
  • Normal liver, kidney, and bone marrow function within specified lab values
  • Good physical condition with ECOG 0 to 2 and no severe comorbidities affecting radiotherapy
  • Adequate major organ function
  • Predicted survival of at least 6 months after treatment
  • Signed informed consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • Glioma diagnosis not confirmed by pathology
  • Unable to lie still for 30 minutes
  • Recurrent tumors receiving secondary treatment
  • Presence of distant metastases or more than two intracranial lesions
  • Prior head radiotherapy with photon, proton, or carbon ions
  • Intracranial radioactive particle implantation with metal implants affecting radiation dose
  • Unable to undergo MRI due to claustrophobia or incompatible implants
  • Pacemakers or metal implants that interfere with radiation or device function
  • Organ dose limits cannot meet preset safe thresholds
  • Pregnancy or lactation
  • Significant weight loss over 20% in past 6 months
  • AIDS or active syphilis
  • Serious uncontrolled systemic diseases or substance abuse
  • Poor compliance or inability to complete treatment and follow-up
  • Other malignant neoplasms except cured skin cancer and stage 0 cervical cancer
  • Contraindications to radiotherapy
  • Participation in other drug trials within 30 days
  • Limited legal capacity
  • Medical history that could interfere with trial or increase risk
  • Investigator judgment deeming trial participation inappropriate or unsafe
  • Inability or unwillingness to understand or consent to treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Heavy Ion Radiotherapy Department

Wuwei, Gansu, China, 733000

Actively Recruiting

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Research Team

X

Xiaojun Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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