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A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer

A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer - Breast Cancer II

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029478
Enrollment
30
Registered
2017-10-10
Start date
2017-10-10
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

Sponsors

QST Hospital, National Institutes for Quantum and Radiological Sciences and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pathologically proven invasive ductal carcinoma or ductal carcinoma in situ. 2. Tumor size <=20 mm on MRI. 3. No massive LVSI or EIC. 4. No lymphenode metastasis (>2 mm). Sentinel lymph node biopsy is performed prior this study. 5. No distant metastasis. 6. Performance status (ECOG) of 0 to 2. 7. 20 years old or older. 8. A life expectancy of at least 6 months. 9. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe complication (e.g. uncontroled lung disease, heart disease, infection, or psychiatric disease). 2. Previous treatment history including surgery, chemotherapy, endocrine therapy, molecular-targeted agents for breast cancer in same side. 3. Active other malignancy 4. The distanse between skin surface and tumor (including EIC) <=5 mm. 5. Previous radiation therapy for breast cancer in same side. 6. Eligible patients for "Breast cancer I". 7. Pregnancy, pregnancy potential. 8. Ptinents who are considered inappropriate by the attending physician due to medical, psychological or other factors.

Design outcomes

Primary

MeasureTime frame
Adverse reaction of normal tissue within 90 days after starting of the treatment.

Secondary

MeasureTime frame
1. Adverse reaction of normal tissue in late phase 2. Local effect (CR rate) 3. Local control rate with recommended dose 4. Breast cosmetic outcomes 5. Progression-free survival period 6. Overall survival period

Countries

Japan

Contacts

Public ContactNoriyuki Okonogi

National Institutes for Quantum and Radiological Sciences and Technology QST Hospital

okonogi.noriyuki@qst.go.jp043-206-3306

Outcome results

None listed

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