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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Fudan University | OTHER |
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This is a multi-center prospective phase 3 clinical trial to explore the efficacy and side effects of standard-dose photon radiation versus standard-dose proton radiation versus carbon ion boost plus standard proton radiation for newly diagnosed glioblastoma. The patients enrolled will be randomly allocated with 1:1:1 to three group: Control Group, standard-dose photon radiotherapy; Study Group A, standard-dose proton radiotherapy; Study Group B, standard-dose proton radiotherapy plus induction carbon-ion radiotherapy boost. The primary endpoint is overall survival (OS).
This multi-center prospective phase 3 clinical trial will enroll 369 patients with newly diagnosed glioblastoma. Patients will be randomly allocated with 1:1:1 to three groups: Control Group, standard-dose photon radiotherapy (60 Gy); Study Group A, standard-dose proton radiotherapy (60 GyE); Study Group B, standard-dose proton radiotherapy (60 GyE) plus induction carbon-ion radiotherapy boost (15GyE/3F). All patients will receive concurrent and adjuvant temozolomide according to the Stupp protocol. The primary endpoint is overall survival (OS). The secondary endpoint is progression-free survival, side effect and quality life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-dose Photon Radiotherapy | Experimental | The patients will receive standard-dose photon radiation (60Gy/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle) |
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| Standard-dose Proton Radiotherapy | Experimental | The patients will receive standard-dose proton radiation (60GyE/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle). |
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| Standard-dose Proton Radiotherapy plus Carbon-Ion Boost | Experimental | The patients will receive carbon-ion radiation boost (15GyE/3F for residual lesion) priot to standard-dose proton radiation (60GyE/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), then adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Multimodal brain imaging-guided radiotherapy using different beams |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The interval from randomization to death | From the pathological confirmation to death, a median of 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | The interval from randomization to progression or death | From randomization to tumor progression, with a median of 3 years. |
| Toxicities | The scores of toxicities are based on CTCAE criteria, which refers to Common Terminology Criteria for Adverse Events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiade J Lu, M.D. | Contact | 021-38296516 | 86 | jiade.lu@sphic.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiade J Lu | Shanghai Proton and Heavy Ion Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Shanghai | Shanghai Municipality | 201321 | China |
The data will be uploaded by excel documents to share the IPD.
On March, 2026
Excel document as the repository will be used for management.
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| From start to 12 months after completion of radiotherapy. |
| Recognitive Function | The assessment of recognitive function is based on MMSE criteria, which refers to Mini-Mental State Examination. | From initiation of radiotherapy to 12 months after completion of radiotherapy. |
| Life Quality | The assessment of life quality is based on ADL criteria, which refers to Activities of Daily Living. | From initiation of radiotherapy to 12 months after completion of radiotherapy. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |