Clinical trial NCT04536649: Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.
Official title: Proton and Heavy Ion Beam Radiation Versus Photon Beam Radiation for Newly Diagnosed Glioblastoma: A Multi-center Prospective Phase 3 Randomized Control Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Glioblastoma
Keywords: Glioblastoma
Carbon-ion Radiotherapy
Proton Radiotherapy
Photon Radiotherapy
Overall Survival
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Ruijin Hospital
name: Fudan University
First posted: 2020-09-02
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: From the pathological confirmation to death, a median of 3 years.
Secondary outcomes:
measure: Progression-free Survival
timeFrame: From randomization to tumor progression, with a median of 3 years.
measure: Toxicities
timeFrame: From start to 12 months after completion of radiotherapy.
measure: Recognitive Function
timeFrame: From initiation of radiotherapy to 12 months after completion of radiotherapy.
measure: Life Quality
timeFrame: From initiation of radiotherapy to 12 months after completion of radiotherapy.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: Jiade J Lu
role: PRINCIPAL_INVESTIGATOR
References: