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Multi-institutional study to evaluate the usefulness of proton therapy for intracranial tumors using normal tissue complication probability model

Evaluation of the usefulness of proton therapy for intracranial tumors using a model-based approach - MBAPT-CNS trial

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000052664
Enrollment
Unknown
Registered
2023-10-31
Start date
2023-04-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma, Meningioma

Interventions

None listed

Sponsors

Hokkaido university
Lead Sponsor
Southern TOHOKU Proton therapy center, University of Tsukuba Hospital, National Cancer Center Hospital East, Aizawa Hospital, Nagoya city university west medical center, Fukui prefectural hospital, Hyogo ion beam medical center, Medipolis Proton Therapy and Research Center, Tsuyama Chuo Hospital, Sapporo Teishinkai hospital, University hospital Kyoto prefectural university of medicine
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among patients with glioma and meningioma who were registered in the proton beam registry database, radiation therapy was started between May 1, 2016 and April 30, 2021, and treatment plan data could be submitted in DICOM format. A person who is capable of outputting information and who has not received a refusal to participate in this research from a research subject or a person who is considered to be able to represent the wishes and interests of the research subject.

Exclusion criteria

Exclusion criteria: 1. Persons of nationality other than Japan 2. Persons who underwent hyperfractionated irradiation (irradiation twice a day) 3. Persons who received proton beam therapy as private practice 4. Persons who have undergone proton beam therapy to areas with a history of radiation therapy 5. Other persons deemed unsuitable as research subjects by the research director

Design outcomes

Primary

MeasureTime frame
Model based normal tissue complication probability (NTCP) (alopecia, hearing inmairment, tinnitus, cognitive disorder, blindness, cataract, brain necrosis, endocrine dysfunction, second malignancy)

Secondary

MeasureTime frame
1. Search for indicators that indicate the validity of plan comparison in planning studies 2. Search for indicators to select patients for whom proton beam therapy is desirable 3. Comparison of actual probability of adverse event occurrence and predicted NTCP (performance evaluation of NTCP model)

Countries

Japan

Contacts

Public ContactKentaro Nishioka

Hokkaido university Global Center for Biomedical Science and Engineering

k.nishioka@pop.med.hokudai.ac.jp011-706-7798

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026