Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.
NCT ID: NCT04536649
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
369 participants
INTERVENTIONAL
2020-10-01
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma
NCT06831773
Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial
NCT03082846
Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas
NCT05737212
Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00053183
Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
NCT02179086
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard-dose Photon Radiotherapy
The patients will receive standard-dose photon radiation (60Gy/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle)
Radiotherapy
Multimodal brain imaging-guided radiotherapy using different beams
Standard-dose Proton Radiotherapy
The patients will receive standard-dose proton radiation (60GyE/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle).
Radiotherapy
Multimodal brain imaging-guided radiotherapy using different beams
Standard-dose Proton Radiotherapy plus Carbon-Ion Boost
The patients will receive carbon-ion radiation boost (15GyE/3F for residual lesion) priot to standard-dose proton radiation (60GyE/30F for high-risk area) with concurrent temozolomide (75mg/m2, qd), then adjuvant temozolomide (150-200mg/m2, qd, D1-5, 28d/cycle).
Radiotherapy
Multimodal brain imaging-guided radiotherapy using different beams
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiotherapy
Multimodal brain imaging-guided radiotherapy using different beams
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RenJi Hospital
OTHER
Ruijin Hospital
OTHER
Fudan University
OTHER
Shanghai Proton and Heavy Ion Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jiade J. Lu
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jiade J Lu
Role: PRINCIPAL_INVESTIGATOR
Shanghai Proton and Heavy Ion Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPHIC-TR-HNCNS-2020-45
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.