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A single center, prospective, single-arm, confirmatory study of accelerated partial breast irradiation using intensity modulated radiotherapy technique after breast conserving surgery.

Confirmatory study of accelerated breast irradiation after breast conserving surgery.

Murofushi Keiko

Tokyo Metropolitan Komagome Hospital

3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan

kmurofushi0918@gmail.com

Shimizuguchi Takuya

Tokyo Metropolitan Komagome Hospital

3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan

+81-3-3823-2101

JASTRO.cick@gmail.com

Recruiting

Jan. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. All of the following conditions were met prior to surgery.
a Single tumor deteceted in MRI.
b No lung metastasis detected in chest X-ray.
c No neoadjuvant treatment.
d No distant metastasis detected in all preoperative examinations.
2. Additional resection during partial mastectomy is allowed.
3. Eligibility criteria of histopathology,
a DCIS/IDC, pTis-1N0M0, tumor size =< 2 cm.
b pN0.
c No cancer cells within 2 mm of resection margin.
d Not multiple tumors.
4. Receiving appropriate adjuvant therapy (may not be necessary).
5. Female (Explanation and consent can be given in Japanese).
6. 50 years or older.
7. ECOG Performance status 0 or 1.
8. No history of radiation therapy to the chest for any disease.
9. Major organ function is preserved.
10. Written informed consent is obtained.

1. Active collagen diseases.
2. Simultaneous or metachronous (within 2 years) multiple cancers.
3. Active infectious disease requiring systemic therapy.
4. Receiving continuous administration of steroids (> 10mg/day) or immunosuppressant treatments.
5. Diabetes mellitus uncontrollable under proper treatment.
6. Other conditions judged as inappropriate for the study by the investigator.

Female

Breast cancer with ductal carcinoma in situ(DCIS) or invasive ductal carcinoma(IDC)

Accelerated partial breast irradiation is performed after partial mastectomy. A dose of 30 Gy in 5 fractions is administered.

The incident rate of 3-year late adverse event (Grade 2 or more)

1) The 5-year ipsilateral breast tumor recurrence rate
2) The 5-year regional lymph node (ipsilateral axillary lymph node, supraclavicular lymph node, parasternal lymph node) recurrence rate
3) The 5-year distant metastasis free survival rate
4) The 5-year tumor recurrence free survival rate
5) The 5-year overall survival rate
6) The 5-year contralateral breast tumor recurrence rate
7) Acute period adverse event incident rate
8) The proportion of patients with worse breast cosmetic changes

+81-3-3823-2101

Dec. 15, 2022

No

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