Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.

Shanghai Proton and Heavy Ion Center369 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

369

Conditions

Glioblastoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival

The interval from randomization to death

Time frame: From the pathological confirmation to death, a median of 3 years.

Secondary Outcomes

Progression-free Survival

The interval from randomization to progression or death

Time frame: 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.

Time frame: 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.

Time frame: 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.