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Phase I/II trial of efficacy and safety of carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801)

Phase I/II trial of efficacy and safety of carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801) - Carbon-ion radiotherapy for post-operative pelvic recurrence of rectal cancer (GUNMA0801)

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000009719
Enrollment
35
Registered
2013-01-08
Start date
2010-06-01
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

Post-operative pelvic recurrence of rectal cancer

Interventions

None listed

Sponsors

Gunma University Heavy-ion Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologiccally or clinically diagnosed post-operative pelvic recurrence of primary rectal cancer 2)Intra-pelvic local recurrence without extra-pelvic recurrence 3)Currative resected primary tumor 4)Measureable tumor 5)Past history of chemotherapy over 4 weeks before treatment 6)Age between 20 and 80 years old 7)PS 0-3 8)Adequate organ functions 9)Informed consent

Exclusion criteria

Exclusion criteria: 1)Tumors if applicable following conditions ; a)Obvious bladder invasion, b)Anastomotic recurrence. 2)Obivious tumor invasion to bowels 3)Past history of irradiation to the target 4)Open wound or uncontrolled infectious disease 5)Uncontrolled severe complication 6)Active double cancers 7)In pregnancy or during the lactation preiod 8)Other medical or psychological unsuitable reasons

Design outcomes

Primary

MeasureTime frame
Local control rate at 3 years

Secondary

MeasureTime 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

None listed

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