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NCT Number: NCT06215495

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

southern medical university affiliated Zhujiang Hospital

Guangzhou, China

Location status: Recruiting

Location contact

Yujing Tan, Doctor

CONTACT

[email protected]

+8662782356

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Radiation

delineate according to EORTC guideline

Primary outcomes

  1. progression-free survival

    Time frame: 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

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

Secondary outcomes

  1. overall survival

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

    confirm if the participant dies every time back to the hospital during screening and follow-up

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

    Time frame: through study completion, up to 3 years

    EORTC-QLQ-C30 questionnaire

  3. radiotherapy complication incidence

    Time frame: through study completion, up to 3 years

Study contacts

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

Yujing Tan, Doctor

CONTACT

[email protected]

+8613560347303

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

A Novel Target Delineation Scheme Based on RTOG(Radiation Therapy Oncology Group) and EORTC(European Organisation for Research and Treatment of Cancer) Guidelines Impact on Survival Time and Radiotherapy Complications in High-grade Glioma Patients: a Single-center Randomized Single-blind Clinical Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2024
Registry last updated
Mar 15, 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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