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Safety test of radiotherapy with Proton beam therapy system

Safety test of radiotherapy with Proton beam therapy system - Safety test of Proton beam therapy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013197
Enrollment
100
Registered
2014-02-21
Start date
2014-03-04
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

Solid tumor

Interventions

Proton beam therapy system

Sponsors

Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with pathologically proved malignant tumor, or pathologically proved benign disease that the effectiveness of X-ray treatment was verified 2) Patients with clinically evident malignant disease 3) Patients with clinically benign disease that the effectiveness of X-ray treatment was verified 4) A well-informed written consent was obtained from the patient (and the person with parental authority if the patient was younger than age 20 years) 5) PS is 0-3 in the criteria of ECOG

Exclusion criteria

Exclusion criteria: 1) with serious active infections in the irradiated sites 2) with severe diabetes that uncontrolled, or treated by using insulin 3) with severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia 4) pregnant or likely to be 5) considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 6) the proposed radiation treatment site had been given tolerance dose in the past 7) Patient who cannot be held rest for about 30 minutes, except the patient younger than 20 years old who can be held rest under sedation 8) weight over 135kg 9) unsuitable for enrollment judged by principal investigator

Design outcomes

Primary

MeasureTime frame
Incidence of the early phase adverse invent induced by radiotherapy using Proton beam therapy system

Secondary

MeasureTime frame
1) changes in tumor volume 2) changes in tumor marker 3) changes in subjective symptoms or QOL

Countries

Japan

Contacts

Public ContactShinichi Shimizu

Hokkaido University Graduate School of Medicine Department of Radiation Oncology

sshing@med.hokudai.ac.jp+81-11-706-5977

Outcome results

None listed

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