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

March 12, 2024 updated by: Zhujiang Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • southern medical university affiliated Zhujiang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: reduced CTV (clinical target volume) and PTV (planning target volume)
Radiation: 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
Active Comparator: EORTC CTV (clinical target volume) and PTV (planning target volume)
Radiation: EORTC (European organisation for research and treatment of cancer) target volume
delineate according to EORTC guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiotherapy complication incidence
Time Frame: through study completion, up to 3 years
through study completion, up to 3 years
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
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)
Time Frame: through study completion, up to 3 years
EORTC-QLQ-C30 questionnaire
through study completion, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Yujing Tan, Doctor, +8613560347303

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2024

Primary Completion (Estimated)

May 28, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-010-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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