Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-80
SponsorGansu Wuwei Tumor Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥14 years and ≤80 years;

Indications: According to the criteria of the 5th edition of WHO Classification of Central Nervous System Tumors published in 2021, histological characteristics and molecular phenotype were integrated, and the molecular phenotype was IDH wild-type glioma and IDH mutant WHO Grade Ⅲ and Ⅳ glioma. They mainly include: IDH wild-type low-grade glioma (Grade 4 astrocytoma according to the 2021 WHO classification definition); Anaplastic Astrocytoma, AA; anaplastic astrocytoma, AA; Anaplastic Oligodendroglioma, AOG; anaplastic oligodendroglioma, AOG; Anaplastic Oligoastrocytoma, AOA; anaplastic oligoastrocytoma, AOA; Glioblastoma Multiforme, GBM. Regardless of surgical completeness, i.e. after total, subtotal, or partial resection, and after stereotactic or craniotomy.

No distant or intraspinal spread and metastasis; A single or two intracranial lesions may be covered by the same radiotherapy plan.

The treatment conditions before this radiotherapy were as follows: First radiotherapy: no interventional, photodynamic or other tumor ablation was performed within 4 weeks before this radiotherapy; The operative wound has fully healed.

Disqualifiers

WHOII-IV glioma unconfirmed by pathology;

Patients who cannot lie still for 30 minutes;

Secondary treatment of recurrent tumors

There have been distant metastases, or scattered or multiple (>2) intracranial lesions;

Trial design

Design model

Single group

Treatments tested in this trial

  • Carbon ion combined with photon radiotherapy

    Radiation

    PTV1 was first treated with photon radiotherapy (started within 30 days after surgery), with a total dose of 50Gy, 25 times; After photon radiotherapy, PTV2 carbon ion radiotherapy was started, the total dose was 24.8Gy(RBE), 8 times. 3.1Gy(RBE)/fx; 1fx/ day, 5 days/week.

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Study groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

Progression-free survival

Time frame
2 years

Secondary outcomes

1

overall survival

overall survival

Time frame
2 years
2

objective remission rate

objective remission rate

Time frame
2 years
3

Disease control rate

Disease control rate

Time frame
2 years

Other outcomes

Sponsors and contacts

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