Phase I trial of safety of carbon-ion radiotherapy for primary malignant bone and soft tissue tumor in the childhood (GUNMA1102)

Phase I trial of safety of carbon-ion radiotherapy for primary malignant bone and soft tissue tumor in the childhood (GUNMA1102) - Carbon-ion radiotherapy for primary malignant bone and soft tissue tumor in the childhood (GUNMA1102)

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009721

Enrollment

Registered

2013-01-08

Start date

2011-09-08

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

Primary malignant bone and soft tissue tumor in the childhood

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologiccally proven primary bone or soft tissue tumor 2) Unresectable tumor or patient's refusal of surgery 3) Resistant tumor to usual chemotherapy and radiotherapy 4) Age between 6 and 16 years old 5) Measureable tumor 6) Expected to survive more than 6 months 7) PS 0-3 8) Informed consent by legal representative

Exclusion criteria

Exclusion criteria: 1) Obvious intravascular embolus in radiographics 2) Artifact affecting dose caliculation 3) Obivious tumor invasion to bowels 4) Past history of chemotherapy within 4 weeks before treatment 5) Uncontrolled infectious disease 6) Past history of irradiation to the target 7) Uncontrolled severe complication 8) Active double cancers 9) Other medical or psychological unsuitable reasons

Design outcomes

Primary

Measure	Time frame
Acute complication rate	—

Secondary

Measure	Time frame
Response rate, local control rate	—

Countries

Japan

Contacts

Public ContactTatsuya Ohno

Gunma University Gunma University Heavy-ion Medical Center

027-220-8378

Outcome results