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.

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.

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