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NCT04536649
Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.
Phase 3 trial testing Radiotherapy in Glioblastoma in 369 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | Shanghai Proton and Heavy Ion Center |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 369 |
| Start date | 1 October 2020 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Radiotherapy — full drug profile →
Conditions studied
- Glioblastoma — all drugs for Glioblastoma →
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):
-
Carbon Ion Radiobiology.
Tinganelli W, Durante M. · · 2020 · cited 180× · PMID 33080914 · DOI 10.3390/cancers12103022 -
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 -
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 -
Factors affecting the radiation response in glioblastoma.
Aiyappa-Maudsley R, Chalmers AJ, Parsons JL. · · 2022 · cited 17× · PMID 36325371 · DOI 10.1093/noajnl/vdac156 -
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 -
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 -
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 -
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:
- PubMed search for NCT04536649
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Proton and Heavy Ion Center trials
Trials by the same sponsor.
- NCT07135661 — Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy · NA · recruiting
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- NCT05878678 — Prospective Study of Particle Radiotherapy for Breast Cancer With Different Arm Position · Phase 2 · unknown
- NCT05692661 — A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04536649 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Proton and Heavy Ion Center
- Last refreshed: 2 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04536649.
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