A phase II clinical trial of carbon-ion radiotherapy for patients with local recurrence after primarily resected rectal cancer (HIMAT1351)

A phase II clinical trial of carbon-ion radiotherapy for patients with local recurrence after primarily resected rectal cancer (HIMAT1351) - Carbon-ion radiotherapy for local recurrence after primarily resected rectal caner (HIMAT1351)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013688

Enrollment

Registered

2014-04-11

Start date

2014-04-11

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

local recurrence after primarily resected rectal cancer

Interventions

Carbon-ion radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven rectal caner 2) local recurrence after primarily resected rectal cancer 3) Recurrence after curative surgical resection (Cur A according to JSCCR Guidelines, the 7th edition) 4) No past history of irradiation to the target 5) Unresectable tumor or patient's refusal of surgery 6) Evaluable tumor 7) No distant metastasis 8) Age between 20 and 80 years old 9) PS 0-2 10) Sufficient major organ function 11) Expected to survival more than 4 months 12) Informed consent by patient

Exclusion criteria

Exclusion criteria: 1) Anastomotic recurrence or invasion to bone or bladder 2) CTV over 15cm 3) CTV including gastrointestinal 4) Past history of chemotherapy within 2 weeks before treatment 5) Uncontrolled infectious disease 6) Active double cancers 7) Severe complicating disease 8) Other medical or psychological unsuitable reasons

Design outcomes

Primary

Measure	Time frame
three year local control rate	—

Secondary

Measure	Time frame
response rate, survival rate, progression free survival, complication rate, pain response	—

Countries

Japan

Contacts

Public ContactKotaro Terashima

SAGA HIMAT Foundation Ion Beam Therapy Center

terashima-kotaro@saga-himat.jp0942-81-1897

Outcome results

None listed

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