Glioblastoma (GBM)NCT07368283
Limited Target Volume Radiotherapy After Glioblastoma Surgery
A study testing limited-field radiotherapy in people with Glioblastoma (GBM), run by Jiangxi Provincial Cancer Hospital.
Trial summary
Research on radiotherapy target volumes for glioblastoma is increasingly focused on exploring more limited yet effective irradiation fields, aiming to achieve local control while minimizing acute and long-term neurotoxicity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- limited-field radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2030
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years.
- Diagnosed with glioblastoma by surgical pathology, with the extent of resection achieving maximal safe resection.
- Within 2 to 6 weeks after surgery
- In good physical condition with a Karnofsky Performance Status (KPS) score ≥ 60.
- Hematological, hepatic, and renal functions are essentially normal.
- Signed informed consent, willing to undergo treatment and follow-up as stipulated in the study protocol.
Who cannot join
- Prior history of cranial radiotherapy or other malignant tumors.
- Severe dysfunction of vital organs (e.g., heart, liver, kidneys) that precludes tolerance to radiotherapy.
- Active infection, immune system disorders, or other serious chronic diseases.
- Pregnancy or lactation.
- Psychiatric disorders or severe cognitive impairment that compromises the ability to cooperate with treatment and follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm Phase II Non-inferiority Clinical Study of Limited Target Volume Radiotherapy After Glioblastoma Surgery
Research on radiotherapy target volumes for glioblastoma is increasingly focused on exploring more limited yet effective irradiation fields, aiming to achieve local control while minimizing acute and long-term neurotoxicity. Previous retrospective analysis by investigators revealed that local recurrences of glioblastoma are predominantly confined to a narrow margin around the original lesion: 98.3% of recurrences occurred within 0.5 cm of the original T2-FLAIR abnormality, 94.8% within 1 cm of the original T1-enhanced region. These findings have been cited in the ESTRO-EANO treatment guidelines. Building on this evidence, investigators plan to conduct a single-arm, phase II clinical trial to systematically evaluate the efficacy and safety of a 1 cm radiotherapy target volume in post-operative glioblastoma patients.Eligible patients with glioblastoma who have undergone surgical resection will be selected to receive limited-field radiotherapy. The target volume will be defined based on the postoperative MRI enhancing lesion: a 1 cm margin will be added to form the clinical target volume (CTV), followed by a further 0.3 cm margin to create the planning target volume (PTV). A total dose of 60 Gy will be delivered in 30 fractions (2 Gy per fraction, 5 fractions per week). Concurrent and adjuvant chemotherapy will be administered per standard guidelines. The primary efficacy endpoints are the 6-month progression-free survival rate and the incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher. Secondary endpoints include overall survival, patterns of recurrence, neurocognitive function, and quality of life.
- Conditions
- Glioblastoma (GBM)
- Being tested
- limited-field radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limited-field radiotherapyRadiation
limited-field radiotherapy + Concurrent and adjuvant TMZ chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| limited-field radiotherapy Group | Other | Not described Receives: Radiation: limited-field radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6m PFS
6-month progression-free survival rate
Measured: up to 6 month
incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher
Measured: Up to 24 months
Secondary outcomes (7)
OS
overall survival
Measured: Up to 24 months
Location of first recurrence relative to radiation field (in-field, marginal, or distant)
The spatial relationship between the first documented site of disease recurrence/progression and the original radiation treatment plan will be determined by a core imaging laboratory. Recurrent lesions will be co-registered with the original planning CT/MRI and radiation dose distribution.
Classification is based on the volume of the recurrent lesion covered by the 95% isodose line of the original prescription dose:
In-field recurrence: >80% of the recurrent lesion's volume is within the 95% isodose line.
Marginal recurrence: 20% to 80% of the recurrent lesion's volume is within the 95% isodose line.
Distant recurrence: <20% of the recurrent lesion's volume is within the 95% isodose line.
This classification criteria is adapted from the dosimetric analysis methods commonly used in radiotherapy studies (e.g., Patterns offailure for glioblastoma multiforme following limited-margin radiation and concurrent temozolomide. Radiation oncology 2014, 9:130.)
Measured: Up to 24 months
Cognitive function assessed by Mini-Mental State Examination (MMSE) score
Cognitive function assessed by the Mini-Mental State Examination (MMSE). Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Up to 24 months
Cognitive function assessed by Montreal Cognitive Assessment (MoCA) score
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Up to 24 months.
Health-Related Quality of Life as assessed by the EORTC QLQ-C30 Global Health Status / QoL scale
Score on the Global Health Status / Quality of Life scale (Items 29 \& 30) of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scale range: 0-100. A higher score indicates a better overall quality of life.
Measured: Up to 24 months
Disease-Specific Quality of Life as assessed by the EORTC QLQ-BN20 summary score
Summary score of the European Organization for Research and Treatment of Cancer Brain Cancer Module (EORTC QLQ-BN20). This scale assesses symptoms and issues specific to brain tumor patients (e.g., future uncertainty, visual disorder, motor dysfunction). Scale range and interpretation should be specified
Measured: Up to 24 months
Quality of Life as assessed by the FACT-Br Total Score
Total score of the Functional Assessment of Cancer Therapy - Brain (FACT-Br). This questionnaire assesses physical, social, emotional, functional well-being, and additional concerns specific to brain tumor patients. Scale range: 0-200. A higher score indicates better quality of life.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiping Chen, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368283
- Sponsor's protocol ID
- 2025ky249
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase II Non-inferiority Clinical Study of Limited Target Volume Radiotherapy After Glioblastoma Surgery
- ClinicalTrials.gov ID
- NCT07368283
- Acronym / sponsor ID
- 2025ky249
- Conditions
- Glioblastoma (GBM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Jan 2026 (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.
Research on radiotherapy target volumes for glioblastoma is increasingly focused on exploring more limited yet effective irradiation fields, aiming to achieve local control while minimizing acute and long-term neurotoxicity. Previous retrospective analysis by investigators revealed that local recurrences of glioblastoma are predominantly confined to a narrow margin around the original lesion: 98.3% of recurrences occurred within 0.5 cm of the original T2-FLAIR abnormality, 94.8% within 1 cm of the original T1-enhanced region. These findings have been cited in the ESTRO-EANO treatment guidelines. Building on this evidence, investigators plan to conduct a single-arm, phase II clinical trial to systematically evaluate the efficacy and safety of a 1 cm radiotherapy target volume in post-operative glioblastoma patients.Eligible patients with glioblastoma who have undergone surgical resection will be selected to receive limited-field radiotherapy. The target volume will be defined based on the postoperative MRI enhancing lesion: a 1 cm margin will be added to form the clinical target volume (CTV), followed by a further 0.3 cm margin to create the planning target volume (PTV). A total dose of 60 Gy will be delivered in 30 fractions (2 Gy per fraction, 5 fractions per week). Concurrent and adjuvant chemotherapy will be administered per standard guidelines. The primary efficacy endpoints are the 6-month progression-free survival rate and the incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher. Secondary endpoints include overall survival, patterns of recurrence, neurocognitive function, and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| limited-field radiotherapy Group | Other | Radiation: limited-field radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 70 years.
- Diagnosed with glioblastoma by surgical pathology, with the extent of resection achieving maximal safe resection.
- Within 2 to 6 weeks after surgery
- In good physical condition with a Karnofsky Performance Status (KPS) score ≥ 60.
- Hematological, hepatic, and renal functions are essentially normal.
Key exclusion criteria (5 listed)
- Prior history of cranial radiotherapy or other malignant tumors.
- Severe dysfunction of vital organs (e.g., heart, liver, kidneys) that precludes tolerance to radiotherapy.
- Active infection, immune system disorders, or other serious chronic diseases.
- Pregnancy or lactation.
- Psychiatric disorders or severe cognitive impairment that compromises the ability to cooperate with treatment and follow-up.
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 |
|---|---|---|
| limited-field radiotherapylimited-field radiotherapy + Concurrent and adjuvant TMZ chemotherapy | Radiation | limited-field radiotherapy Group |
Primary outcome
6m PFS
Time frame: up to 6 month
6-month progression-free survival rate
incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher
Time frame: Up to 24 months
7 secondary outcomes
OS
Time frame: Up to 24 months
Location of first recurrence relative to radiation field (in-field, marginal, or distant)
Time frame: Up to 24 months
Cognitive function assessed by Mini-Mental State Examination (MMSE) score
Time frame: Up to 24 months
Cognitive function assessed by Montreal Cognitive Assessment (MoCA) score
Time frame: Up to 24 months.
Health-Related Quality of Life as assessed by the EORTC QLQ-C30 Global Health Status / QoL scale
Time frame: Up to 24 months
Disease-Specific Quality of Life as assessed by the EORTC QLQ-BN20 summary score
Time frame: Up to 24 months
Quality of Life as assessed by the FACT-Br Total Score
Time frame: Up to 24 months
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 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Glioblastoma (GBM)
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
Questions about this trial
What is this clinical trial studying?
A study testing limited-field radiotherapy in people with Glioblastoma (GBM), run by Jiangxi Provincial Cancer Hospital.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ziwei Tu (13755793552, tuziwei198803@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6m PFS (time frame: up to 6 month). The study lists 2 primary outcomes in all. 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 30 Jan 2026.