Phase I/II trial of efficacy and safety of carbon-ion radiotherapy for primary malignant bone and soft tissue tumor (GUNMA0904)

Phase I/II trial of efficacy and safety of carbon-ion radiotherapy for primary malignant bone and soft tissue tumor (GUNMA0904) - Carbon-ion radiotherapy for primary malignant bone and soft tissue tumor (GUNMA0904)

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009720

Enrollment

Registered

2013-01-08

Start date

2010-08-01

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologiccally proven primary bone or soft tissue tumor 2) Without lymph node and/or distant metastasis 3) Measureable tumor 4) Age between 16 and 80 years old 5) PS 0-3 6) Informed consent

Exclusion criteria

Exclusion criteria: 1) Primary head tumor 2) Obvious intravascular embolus in radiographics 3) Artifact affecting dose caliculation 4) Obivious tumor invasion to bowels 5) Past history of chemotherapy within 4 weeks before treatment 6) Uncontrolled infectious disease 7) Past history of irradiation to the target 8) Uncontrolled severe complication 9) Active double cancers 10) In pregnancy or during the lactation preiod 11) Other medical or psychological unsuitable reasons

Design outcomes

Primary

Measure	Time frame
Local control rate at 2 years	—

Secondary

Measure	Time frame
Response rate, progression-free survival rate, overall survival rate, acute complication rate, late complication rate, QOL	—

Countries

Japan

Contacts

Public ContactTatsuya Ohno

Gunma University Gunma University Heavy-ion Medical Center

027-220-8378

Outcome results