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A study on the safety and efficacy of hypofractionated radiotherapy in post-operative irradiation for breast cancer patients

A study on the safety and efficacy of hypofractionated radiotherapy in post-operative irradiation for breast cancer patients - A study of hypofractionated radiotherapy for breast cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010977
Enrollment
400
Registered
2013-06-17
Start date
2013-05-17
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

For cases of post breast conserving surgery without high grade factors (age &lt
50, positive axillary nodes, lymphovascular invasion, or close margins)- 43.2 Gy to the whole breast in 16 fractions over 22 days for (tumor bed boosts are not performed) For cases of post breast cons

Sponsors

National Institutes for Quantum and Radiological Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Eligibility criteria for HF-WBI Patient who has undergone BCT and have been histopathologically confirmed to have breast cancer The size of primary tumor is either Tis, T1 or T2 Patient who has undergone a lymph node dissection (including sentinel lymph node biopsy) and has been histopathologically confirmed to have 3 positive lymph nodes or less. Consent of the patient for the trial obtained 2. Eligibility criteria for HF-PMRT Patient who has undergone any type of mastectomy and have been histopathologically confirmed to have breast cancer Patient without positive margin. Patient who has undergone a lymph node dissection (including sentinel lymph node biopsy) and has been histopathologically confirmed to have less than 8 positive lymph nodes. Consent of the patient for the trial obtained

Exclusion criteria

Exclusion criteria: Internal mammary lymph node metastasis. Residual axillary lymph node or who need to irradiate axially region. Distant metastasis. Any active collagen disease Active double primary cancer (except for carcinoma in situ and bilateral breast cancer) Concurrent chemoradiotherapy Previous chest irradiation Pregnancy and potential pregnancy

Design outcomes

Primary

MeasureTime frame
Local recurrence-free survival rate (in radiation fields)

Secondary

MeasureTime frame
Acute adverse events (the skin, subcutaneous tissue, breast tissue, and lungs) Late advese events (the skin, subcutaneous tissue, breast tissue, lungs, ribs and the heart) Cosmetic outcome

Countries

Japan,Asia(except Japan)

Contacts

Public ContactKumiko Karasawa

National Institutes for Quantum and Radiological Science and Technology QST Hospital

kkarasaw@gmail.com043-206-3306

Outcome results

None listed

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