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Radical radiotherapy using single-fraction carbon-ion beams for early-stage breast cancer: Phase I/II trial

Radical radiotherapy using single-fraction carbon-ion beams for early-stage breast cancer: Phase I/II trial - Breast III

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041032
Enrollment
45
Registered
2020-07-27
Start date
2020-07-27
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

breast cancer

Interventions

Sponsors

National Institutes for Quantum and Radiological Sciences and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Patholog ically proven ductal carcinoma in situ or invasive ductal carcinoma (usual type) 2.Single lesion, tumor 2 cm or less on MRI: which is classified as Stage 0-I (UICC) 3.No lymphovascular space involvement, no extensive intraductal carcinoma 4.Luminal A like sub type (in case the patient has IDC) 5.Performance status 0 to 2 6.Age 50 years old and over 7.No other life-threatening illness 8.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Severe complication 2.Previous treatment for the breast cancer 3.Active double primary tumor 4.Tumor invasion to skin or chest wall 5.Distance between tumor border to skin less than 5mm 6.Previous irradiation at tumor site 7.Medically, psychologically or other reason who are not suitable for candidate

Design outcomes

Primary

MeasureTime frame
In phase I: Acute toxicities of normal tissue Evaluation of dose limiting toxicities In phase II: Primary local effect (non-PD rate)

Countries

Japan

Contacts

Public ContactNoriyuki Okonogi

National Institutes for Quantum and Radiological Sciences and Technology QST Hospital

okonogi.noriyuki@qst.go.jp043-206-3306

Outcome results

None listed

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