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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhujiang Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: reduced CTV (clinical target volume) and PTV (planning target volume)Experimental treatment 1 intervention
Group B: EORTC CTV (clinical target volume) and PTV (planning target volume)Active comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

overall survival

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

Time frame
From date of randomization until the date of death from any cause, assessed up to 3 year
2

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

EORTC-QLQ-C30 questionnaire

Time frame
through study completion, up to 3 years
3

radiotherapy complication incidence

Time frame
through study completion, up to 3 years

Other outcomes

Sponsors and contacts

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