A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer

A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer - A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016206

Enrollment

Registered

2015-01-13

Start date

2014-10-21

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

Proton therapy 60 to 72GyE/10Fr/12days

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Pathologically proven invasive ductal carcinoma(normal type). 2.Tumor size is 2cm or less on MRI.UICC clinical stageI(T1N0M0) 3. No Lymphovascular space invasion(LVSI), No extensive intraductal component(EIC),Estrogen receptor positive. 4.Performance status 0 to 2. 5.Age 50 years old and over. 6.No other life-threatening illness. 7.Surgery is difficult,surgery has denied herself. 8.Written informed consent

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 1cm on MRI. 6.Previous irradiation at tumor site 7. Non invasive ductal carcinoma (pure DCIS) 8. Medically, psychologically or other reason who are not suitable for candidate. 9. History of connective tissue diseases

Design outcomes

Primary

Measure	Time frame
1.Acute toxicities of normal tissue 2.Local control	—

Countries

Japan

Contacts

Public ContactYoshitaka Sato

Fukui Prefectural Hospital Proton Therapy Center

y-satou-xn@pref.fukui.lg.jp0776-54-5151

Outcome results

None listed

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