Phase II study of Intraoperative radiation therapy in early breast cancer

Phase II study of Intraoperative radiation therapy in early breast cancer - Phase II study of Intraoperative radiation therapy in early breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003578

Enrollment

140

Registered

2010-05-10

Start date

2010-05-01

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

early breast cancer

Interventions

Intraoperative radiotherapy for breast conservative operation

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) T>2.5cm 2) N0 3) hope for breast conservative operation 4) age older than 50 years 5) marjin is more than 1cm 6) diagnosed marjin is free pathologically intraoperation 7) patologically lymph node negative 8) informed consent is signed

Exclusion criteria

Exclusion criteria: 1) contraindications to radiation therapy 2) past given the radiation therapy for breast or chest 3) have extensive intraductal component 4) have a tumor located in the axillary tail of the breast

Design outcomes

Primary

Measure	Time frame
efficacy (ispirateral local recurrence rate)	—

Secondary

Measure	Time frame
safety, cosmetic evaluation, historical control, evaluation of irradiated volume	—

Countries

Japan

Contacts

Public ContactMasataka Sawaki

Aichi Cancer Center Hospital Breast Oncology

sawapi@qc4.so-net.ne.jp052-762-6111

Outcome results

None listed

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