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A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer

A phase I/II clinical study of Carbon Ion Radiotherapy using 1 fraction for Liver Metastasis from Colorectal Cancer - Dose escalation study of Carbon Ion Radiotherapy for CLM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032911
Enrollment
30
Registered
2018-06-07
Start date
2006-04-01
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

Colon cancer liver metastasis

Interventions

Prescribed heavy-ion beam (carbon-ion beam) dose. Initial dose 36Gy(RBE). Dose escalated until dose limiting toxicity is met.

Sponsors

National Institutes for Quantum and Radiological Sciences and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This study included patients who: 1. has colorectal cancer liver metastasis diagnosed by radiological and clinical findings 2. with Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. 3. had primary colorectal lesions and lymph node metastasis removed totally by surgery (R0 resection) at least 4 weeks prior to enrollment and primary lesions to be histologically proven as CRC 4. have not received chemotherapy for at least 4 weeks prior to enrollment.

Exclusion criteria

Exclusion criteria: This study excluded patients who: 1. has evident vascular invasion. 2. had prior treatment to the specific lesion, 3. with lesions close to the intestine (less than 5 mm), 4. with uncontrollable ascites, 5. with severe liver damage, 6. with active coexisting malignancy, 7. with extra-hepatic lesions including local recurrence 8. were pregnant.

Design outcomes

Primary

MeasureTime frame
Acute toxicity and initial tumor response

Countries

Japan

Contacts

Public ContactHirokazu Makishima

National Institutes for Quantum and Radiological Sciences and Technology National Institutes of Radiological Sciences

makishima.hirokazu@qst.go.jp043-206-3306

Outcome results

None listed

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