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Safety and efficacy trial of accelerated partial breast irradiation with 3-dimentional conformal radiation therapy for stage 0, 1, and 2 breast cancer

Safety and efficacy trial of accelerated partial breast irradiation with 3-dimentional conformal radiation therapy for stage 0, 1, and 2 breast cancer - APBI with 3D-CRT for breast cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003405
Enrollment
71
Registered
2010-03-30
Start date
2008-01-01
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

breast cancer after breast-preserving surgery

Interventions

Accelerated radiation therapy (38.5 Gy/10 fr/ 2 weeks) for partial breat.

Sponsors

National Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)clinical stage 0-2 breast cancer with 3 cm or less of histological tumor diameter 2) pathohistological comfirmed non-inasive carcinoma, invasive carcinoma, or specific type excluding squamous cell carcinoma 3)solitary tumor 4)20 years old or more 5) breast-preserving surgery with lumpectomy or segmental mastectomy 6) more than 5mm of surgical margins 7)inserted surgical clips in the surgical margin of the tumor 8)axillary lymph node dissection with level I or II, or histologically negative sentinel lymph nodes. allowance for no axillary dissection in DCIS 9) 3 and less axillary lymph nodes metastases 10) Performance status of 0-2. 11) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) prior radiation therapy against the thoracic. 2) neoadjuvant chemotherapy and/or hormonal therapy 3) Infection with systemic therapy indicated. 4) Scleroderma, systemic lupus erythematosus, dermatomyositis 5) Women during pregnancy

Design outcomes

Primary

MeasureTime frame
Frequency and severity of adverse events of radiotherapy

Secondary

MeasureTime frame
ipsilateral breast recurrence-free survival, relationship of recurrent site of breast and CTV, disease-free survival, overall survival, proportion of deterioration of breast cosmetic outcomes,

Countries

Japan

Contacts

Public ContactYoshikazu Kagami

National Cancer Center Hospital Radiation Oncology Division

03-3542-2511

Outcome results

None listed

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