Radiation ToxicityNCT06215495
A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial
A study testing reduced target volume and EORTC (European organisation for research and treatment of cancer) target volume in people with Radiation Toxicity and MRI Simulated Positioning, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiation Toxicity, MRI Simulated Positioning, High Grade Glioma
- What is being tested?
- reduced target volume and EORTC (European organisation for research and treatment of cancer) target volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
southern medical university affiliated Zhujiang Hospital
Guangzhou
Yujing Tan, Doctor, +8662782356, tanyujing-1981@163.com
About this study
Official 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
The main question it aims to answer are:
- whether the new target delineation scheme can improve Progression-free Survival
- 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
- Being tested
- reduced target volume, EORTC (European organisation for research and treatment of cancer) target volume
- Medical subject headings
- Radiation Injuries, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced target volumeRadiation
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 volumeRadiation
delineate according to EORTC guideline
| Study group | Role | What they receive |
|---|---|---|
| reduced CTV (clinical target volume) and PTV (planning target volume) | Experimental | Not described Receives: Radiation: reduced target volume |
| EORTC CTV (clinical target volume) and PTV (planning target volume) | Active comparator | Not described Receives: Radiation: EORTC (European organisation for research and treatment of cancer) target volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
confirm if the participant dies every time back to the hospital during screening and follow-up
Measured: 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)
EORTC-QLQ-C30 questionnaire
Measured: through study completion, up to 3 years
radiotherapy complication incidence
Measured: through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start18 Feb 2024
- Primary completion28 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ToxicityStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yujing Tan, Doctor, Principal investigator, +8613560347303
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215495
- Sponsor's protocol ID
- 2024-KY-010-01
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06215495
- Acronym / sponsor ID
- 2024-KY-010-01
- Conditions
- Radiation Toxicity, MRI Simulated Positioning, High Grade Glioma, Progression-free Survival, Overall Survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 28 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main question it aims to answer are:
- whether the new target delineation scheme can improve Progression-free Survival
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reduced target volumeDelineate 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 | Radiation | reduced CTV (clinical target volume) and PTV (planning target volume) |
| EORTC (European organisation for research and treatment of cancer) target volumedelineate according to EORTC guideline | Radiation | EORTC CTV (clinical target volume) and PTV (planning target volume) |
Primary outcome
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
3 secondary outcomes
overall survival
Time frame: 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
radiotherapy complication incidence
Time frame: through study completion, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yujing Tan, Doctor principal investigator
+8613560347303
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reduced target volume and EORTC (European organisation for research and treatment of cancer) target volume in people with Radiation Toxicity and MRI Simulated Positioning, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yujing Tan, Doctor (+8613560347303, tanyujing-1981@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.