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

NCT06215495 | Recruiting

• 1 other identifier: 2024-KY-010-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The main question it aims to answer are:

1. 1.whether the new target delineation scheme can improve Progression-free Survival
2. 2.whether it can reduce the incidence of radiation complications in high-grade glioma patients.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  confirm if the participant's cancer progresses or he/she dies every time back to the hospital during screening and follow-up

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcomes (3)

• overall survival

  From date of randomization until the date of death from any cause, assessed up to 3 year

• European organisation for research and treatment of cancer QLQ-C30 (EORTC-QLQ-C30)

  through study completion, up to 3 years

• radiotherapy complication incidence

  through study completion, up to 3 years

Study Arms (2)

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

EXPERIMENTAL

Radiation: reduced target volume

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

ACTIVE COMPARATOR

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

Interventions

reduced target volume 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

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

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

delineate according to EORTC guideline

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High-grade glioma (2021 WHO grade III or IV)
• Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70
• result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential
• The patient voluntarily joined this study and signed an informed consent form
• Willing to return for follow-up
• Willing to provide tissue and blood samples for this research
• Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)
• Radiotherapy within 4-6 weeks after surgery
• No contraindications for taking temozolomide

You may not qualify if:

• Low-grade glioma(2021 WHO grade I or II)
• had or having other type of malignant cancers
• not having been performed gross total resection of tumor
• 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；
• Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia;
• 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)
• Unable to perform brain magnetic resonance imaging;
• Allergic to CT contrast agent, unable to perform enhanced CT examination;
• Remote transfer;
• Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

southern medical university affiliated Zhujiang Hospital

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Radiation Injuries; Glioma

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Yujing Tan, Doctor

  +8613560347303

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujing Tan, Doctor

CONTACT

+8613560347303; tanyujing-1981@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: January 22, 2024
• Study Start: February 18, 2024
• Primary Completion (Estimated): May 28, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-01

Locations

CN (1)