Proton and Heavy Ion Beam Radiation Versus Photon Beam Radiation for Newly Diagnosed Glioblastoma: A Multi-center Prospective Phase 3 Randomized Control Clinical Trial.
Trial ID: NCT04536649
Interventional - Phase 3 - Unknown status
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
Glioblastoma
Interventions
Radiotherapy
Eligibility
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