Glioblastoma
Conditions
Keywords
Glioblastoma, Carbon-ion Radiotherapy, Proton Radiotherapy, Photon Radiotherapy, Overall Survival
Brief summary
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).
Detailed description
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.
Interventions
RADIATIONRadiotherapy
Multimodal brain imaging-guided radiotherapy using different beams
Sponsors
RenJi Hospital
Ruijin Hospital
Fudan University
Shanghai Proton and Heavy Ion Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From the pathological confirmation to death, a median of 3 years. | The interval from randomization to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | From randomization to tumor progression, with a median of 3 years. | The interval from randomization to progression or death |
| Toxicities | From start to 12 months after completion of radiotherapy. | The scores of toxicities are based on CTCAE criteria, which refers to Common Terminology Criteria for Adverse Events. |
| Recognitive Function | From initiation of radiotherapy to 12 months after completion of radiotherapy. | The assessment of recognitive function is based on MMSE criteria, which refers to Mini-Mental State Examination. |
| Life Quality | From initiation of radiotherapy to 12 months after completion of radiotherapy. | The assessment of life quality is based on ADL criteria, which refers to Activities of Daily Living. |
Countries
China
Contacts
Primary ContactJiade J Lu, M.D.
Outcome results
None listed