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Breast III

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032200066
Enrollment
45
Registered
2020-07-09
Start date
2020-12-03
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 Breast cancer

Interventions

Carbon-ion radiotherapy (C-ion RT) is performed using medical heavy particle accelerator (HIMAC) installed at National Institute of Radiological Sciences. The irradiation range includes the tumor iden

Sponsors

Kobayashi Kana
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Pathologically 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 with

Exclusion criteria

Exclusion criteria: 1.Severe complication 2.Previous treatment 3.Active double primary 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 limitting toxicities In phase II: Preliminary local effect (non-PD rate)

Secondary

MeasureTime frame
In phase I: Adverse reaction of normal tissue in late phase Preliminary local effect (non-PD rate) Breast cosmetic outcomes QOL at 2 years after the treatment In phase II: Adverse reaction of normal tissue in acute phase Adverse reaction of normal tissue in late phase Local control rate at 2 years Breast cosmetic outcomes Progression-free survival period Overall survival period QOL at 2 years after the treatment

Contacts

Public ContactMasaru Wakatsuki

QST Hospital, National Institutes for Quantum Science and Technology

wakatsuki.masaru@qst.go.jp+81-43-206-3306

Outcome results

None listed

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