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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| limited-field radiotherapy Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| limited-field radiotherapy | Radiation | limited-field radiotherapy + Concurrent and adjuvant TMZ chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6m PFS | 6-month progression-free survival rate | up to 6 month |
| incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | 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.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziwei Tu | Contact | 13755793552 | tuziwei198803@163.com |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| 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. | 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. | 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. | 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 | 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. | Up to 24 months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |