Clinical trial · Interventional
Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.
Proton and Heavy Ion Beam Radiation Versus Photon Beam Radiation for Newly Diagnosed Glioblastoma: A Multi-center Prospective Phase 3 Randomized Control Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Standard-dose Photon Radiotherapy
- description
- 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)
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Standard-dose Proton Radiotherapy
- description
- 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).
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age\> 18 years old and \<80 years old * Pathologically confirmed newly-diagnosed GBM * Redisual lesion after subtotal resection, partial resection, or biopsy * No dissemination or metastasis in the spinal canal, single lesion, supratentorial lesion * ECOG score 0-1 * Sign the informed consent form before starting the research Exclusion Criteria: * No pathological confirmed evidence of GBM * Multiple lesions or distant spread indicated by imaging studies * Receive conventional photon/proton/carbon ion radiation therapy on the head * Received intracranial radioactive particle implantation * A history of malignant tumors or multiple primary tumors (except skin basal cell carcinoma) * Positive pregnancy test for women of childbearing age * With the accompanying diseases or conditions affect the safety of patients during normal enrollment or research * Active mental disorders or other mental disorders that affect the patients ability to sign informed consent and understand * Uncontrolled active infection
References
Publications (0)
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