Study for the effectiveness of targeted intraoperative radiotherapy instead of tumor bed radiation in breast cancer patients after breast conserving surgery

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900023635

Enrollment

Unknown

Registered

2019-06-04

Start date

2019-07-01

Completion date

Unknown

Last updated

2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Case series:targeted intraoperative radiotherapy

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) patients with histological or cytological diagnosis of breast cancer and breast preservation needs; (2) aged 18 to 70 years old; (3) the ratio of lump to breast is suitable for breast-conserving surgery; (4) single breast mass, no extensive calcification, mass =40mm; (5) non-central mass; (6) no vascular collagenous disease; (7) negative surgical margin; (8) tumor cavity diameter =5cm; (9) the distance between tumor cavity and skin is more than 1cm; (10) the subjects understand the characteristics of the clinical trial and have the ability to bear the corresponding consequences; (11) sign the written consent before the operation; (12) the subjects understand the characteristics of the clinical trial and have the ability to bear the corresponding consequences; (13) feasibility of implementing IORT (for example, surgical incision can be put into applicator).

Exclusion criteria

Exclusion criteria: (1) patients with multiple central lesions, which are far apart and cannot be completely resected in one segment; (2) patients with large or diffuse suspected microcalcification lesions; (3) inflammatory breast cancer patients; (4) patients with positive cutting edge after multiple resection; (5) patients who refuse breast preservation surgery; (6) active connective tissue disease, such as scleroderma, systemic lupus erythematosus or collagen vascular disease; (7) patients with ipsilateral breast who have received radiotherapy of breast or chest wall; (8) tumor cavity diameter > 5cm; (9) participate in other clinical trials; (10) unwilling to sign the informed consent; (11) persons without full capacity for civil conduct.

Design outcomes

Primary

Measure	Time frame
Local control rate;	—

Countries

China

Contacts

Public ContactQu Baolin

Chinese PLA General Hospital

Qubl6212@sina.com+86 13661249243

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026