A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial

NCT ID: NCT06215495

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-18
• Study Completion Date: 2027-06-01

Brief Summary

The main question it aims to answer are:

1. whether the new target delineation scheme can improve Progression-free Survival

2. whether it can reduce the incidence of radiation complications in high-grade glioma patients.

Participants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of EORTC(European organisation for research and treatment of cancer) target delineation method.Temozolomide 75 mg / ( m² · d ) will be given to both groups of patients during radiotherapy. After radiotherapy, its dose changes to 150 ~ 200 mg / ( m² · d ) for 5 days and stopped for 23 days as a cycle. There are 6 cycles in total.

Conditions

Radiation Toxicity; MRI Simulated Positioning; High Grade Glioma; Progression-free Survival; Overall Survival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

reduced CTV (clinical target volume) and PTV (planning target volume)

Group Type: EXPERIMENTAL

reduced target volume

Intervention Type: RADIATION

Delineate residual tumor(GTVp) and tumor bed(GTVtb) on enhanced contrast CT-MRI(T2 fluid attenuated inversion recovery, T2 FLAIR) fusion images. GTVtb and GTVp are expanded by 1cm to CTV_6000.

The clinical target volume_6000 cGy (CTV_6000) is partially reduced beyond the skull and midline. According to the CT-MRI(T2 FLAIR) fusion images, the edema area that cannot be seen on contrast-enhanced CT and only can be seen on MRI should be included.

If CTV_6000 includes thalamus, basal ganglia, brainstem or motor cortex, dose of these areas will be limited no more than 54Gy

EORTC CTV (clinical target volume) and PTV (planning target volume)

Group Type: ACTIVE_COMPARATOR

EORTC (European organisation for research and treatment of cancer) target volume

Intervention Type: RADIATION

delineate according to EORTC guideline

Interventions

reduced target volume

Delineate residual tumor(GTVp) and tumor bed(GTVtb) on enhanced contrast CT-MRI(T2 fluid attenuated inversion recovery, T2 FLAIR) fusion images. GTVtb and GTVp are expanded by 1cm to CTV_6000.

The clinical target volume_6000 cGy (CTV_6000) is partially reduced beyond the skull and midline. According to the CT-MRI(T2 FLAIR) fusion images, the edema area that cannot be seen on contrast-enhanced CT and only can be seen on MRI should be included.

If CTV_6000 includes thalamus, basal ganglia, brainstem or motor cortex, dose of these areas will be limited no more than 54Gy

Intervention Type: RADIATION

EORTC (European organisation for research and treatment of cancer) target volume

delineate according to EORTC guideline

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. High-grade glioma (2021 WHO grade III or IV)

2. Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70

3. result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential

4. The patient voluntarily joined this study and signed an informed consent form

5. Willing to return for follow-up

6. Willing to provide tissue and blood samples for this research

7. Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)

8. Radiotherapy within 4-6 weeks after surgery

9. No contraindications for taking temozolomide

Exclusion Criteria

1. Low-grade glioma(2021 WHO grade I or II)

2. had or having other type of malignant cancers

3. not having been performed gross total resection of tumor

4. Severe active comorbidities, systemic diseases or other serious comorbidities that would render the patient unsuitable for participation in this study or seriously interfere with the appropriate evaluation of the safety and toxicity of the prescribed regimen in the judgment of the investigator, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or mental illness；

5. Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia;

6. Pregnancy or lactation, or pregnancy or childbirth during the expected trial period(from pre-screening or screening visits until 120 days after the last trial treatment)

7. Unable to perform brain magnetic resonance imaging;

8. Allergic to CT contrast agent, unable to perform enhanced CT examination;

9. Remote transfer;

10. Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yujing Tan, Doctor

Role: PRINCIPAL_INVESTIGATOR

+8613560347303

Locations

southern medical university affiliated Zhujiang Hospital

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yujing Tan, Doctor

Role: CONTACT

tanyujing-1981@163.com

+8613560347303

Facility Contacts

Yujing Tan, Doctor

Role: primary

tanyujing-1981@163.com

+8662782356

Other Identifiers

2024-KY-010-01

Identifier Type: -

Identifier Source: org_study_id