A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation

A phase II clinical trial of carbon-ion radiotherapy for pelvic recurrent rectal cancer in patients with prior pelvic carbon-ion irradiation - Carbon-ion re-irradiation for pelvic recurrent rectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022731

Enrollment

Registered

2016-06-14

Start date

2016-06-10

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

pelvic recurrent rectal cancer

Interventions

Heavy-ion particle irradaition 70.4Gy(RBE)/16fractions/4weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmation of locally recurrent colorectal cancers in patients with prior carbon-ion irradiation 2. No invasion to digestive tracts, bladder or urethra 3.Not indicated for curative resection or does not wish to undergo surgery. 4.Has evaluable disease. 5.Without distant metastases by CT, MRI and PET findings 6. 20 years or older 7. Performance status between 0 and 2 8. Normal function of main organs 9.Presumed to be alive for at least 3 months. 10.Written consent to participate in this study has been obtained from the patient.

Exclusion criteria

Exclusion criteria: 1. Diameter of treatment volume longer than 15cm 2.Patient receive chemotherapy within 2 weeks 3. If they have an open wound or a active inflammatory disease 4. If they have a concomitant malignancy 5. If they have a severe heart diseases, a severe cerebrovascular disorder, a severe diabetes, angina pectoris, cardiac infarction. 6.In appropriate for this clinical study because of mental disorder, or other severe concurrent disease. 7.Adults and minors who do not have the capacity to consent.

Design outcomes

Primary

Measure	Time frame
3 years survival rates	—

Countries

Japan

Contacts

Public ContactShigeru Yamada

National Institute for Quantum and Radiological Sciences and Technology QST Hospital

yamada.shigeru@qst.go.jp043-206-3306

Outcome results

None listed

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