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A phase II clinical trial of Carbon-ion therapy for patients with bone and soft tissue sarcomas not suited for surgical resection

A phase II clinical trial of Carbon-ion therapy for patients with bone and soft tissue sarcomas not suited for surgical resection - Carbon-ion radiotherapy for inoperative bone and soft tissue sarcomas (iROCK-1503BS)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021557
Enrollment
40
Registered
2016-03-24
Start date
2016-03-24
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

Bone and soft tissue tumor

Interventions

Carbon-ion radiotherapy A total of 70.4 GyE consisting of 16 fractions
4.4 GyE /day for 6 or 8 times for 2 weeks

Sponsors

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically diagnosed as primary bone and soft tissue sarcomas 2) Inoperative patient (a) Diagnosed as inoperative tumor by specialized surgeons (b) Refused by patient 3) Patient with measurable tumor 4) 16 years or older and 80 years or younger of age at registration of clinical trial 5) 0 to 2 of ECOG performance status 6) Patient without remote metastasis 7) 6 months or longer of expected survival 8) Informed consent given with document

Exclusion criteria

Exclusion criteria: 1) Primary cranial tumor 2) Past history of radiotherapy for the target lesion 3) Ongoing chemotherapy or within 2 weeks after completion of the chemotherapy 4) Patient with active double cancer 5) Patient with active and intractable infection in the target lesion 6) Patient with artifacts which influence the calculation of irradiation dose 7) Other medical or psychological condition which is unsuitable for carbon-ion therapy

Design outcomes

Primary

MeasureTime frame
Local control rate at 2 years

Secondary

MeasureTime frame
1) Overall survival 2) Progression free survival 3) Adverse event rate 4) Quality of life

Countries

Japan

Contacts

Public ContactHiroyuki Katoh

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center

hkatoh@kcch.jp045-520-2222

Outcome results

None listed

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