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NCT04536649

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

Status unknown Phase 3 Last updated 2 September 2020
What this trial tests

Phase 3 trial testing Radiotherapy in Glioblastoma in 369 participants. Status unknown.

Timeline
1 October 2020
Primary endpoint
30 September 2023
30 September 2025

Quick facts

Lead sponsorShanghai Proton and Heavy Ion Center
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment369
Start date1 October 2020
Primary completion30 September 2023
Estimated completion30 September 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Proton and Heavy Ion Center — full company profile →

Who can join

Adults 18 to 80, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Carbon Ion Radiobiology.
    Tinganelli W, Durante M. · · 2020 · cited 180× · PMID 33080914 · DOI 10.3390/cancers12103022
  2. Proton versus photon radiation therapy: A clinical review.
    Chen Z, Dominello MM, Joiner MC, Burmeister JW. · · 2023 · cited 32× · PMID 37064131 · DOI 10.3389/fonc.2023.1133909
  3. MDM2/X Inhibitors as Radiosensitizers for Glioblastoma Targeted Therapy.
    Miles X, Vandevoorde C, Hunter A, Bolcaen J. · · 2021 · cited 26× · PMID 34307171 · DOI 10.3389/fonc.2021.703442
  4. Factors affecting the radiation response in glioblastoma.
    Aiyappa-Maudsley R, Chalmers AJ, Parsons JL. · · 2022 · cited 17× · PMID 36325371 · DOI 10.1093/noajnl/vdac156
  5. Review of Novel Surgical, Radiation, and Systemic Therapies and Clinical Trials in Glioblastoma.
    Valerius AR, Webb LM, Thomsen A, Lehrer EJ, et al · · 2024 · cited 16× · PMID 39408897 · DOI 10.3390/ijms251910570
  6. Flourish of Proton and Carbon Ion Radiotherapy in China.
    Li Y, Li X, Yang J, Wang S, et al · · 2022 · cited 9× · PMID 35237518 · DOI 10.3389/fonc.2022.819905
  7. Charged particle therapy for high-grade gliomas in adults: a systematic review.
    Wang Y, Liu R, Zhang Q, Dong M, et al · · 2023 · cited 8× · PMID 36755321 · DOI 10.1186/s13014-022-02187-z
  8. The Majority of United States Citizens With Cancer do not Have Access to Carbon Ion Radiotherapy.
    Foote RL, Tsujii H, Imai R, Tsuji H, et al · · 2022 · cited 7× · PMID 35875126 · DOI 10.3389/fonc.2022.954747

Verify or expand the search:

Other trials of Radiotherapy

Trials testing the same drug.

Other recruiting trials for Glioblastoma

Currently open trials in the same condition.

Other Shanghai Proton and Heavy Ion Center trials

Trials by the same sponsor.

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Data sources for this page

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