Confirmatory study of accelerated breast irradiation after breast conserving surgery.

Phase 2

Recruiting

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

• Registration Number: JPRN-jRCT1032220561
• Lead Sponsor: Murofushi Keiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-11
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

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. 60 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified