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

NCT04536649 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2020-09-02

No results posted yet for this study

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).

Conditions

Interventions

RADIATION

Radiotherapy

Multimodal brain imaging-guided radiotherapy using different beams

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Shanghai Proton and Heavy Ion Center

    lead OTHER

Principal Investigators

  • Jiade J Lu · Shanghai Proton and Heavy Ion Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-09-30
Completion
2025-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04536649 on ClinicalTrials.gov