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Prospective randomized controlled clinical study of hypofractionated whole breast irradiation following simultaneous integrated boost / sequential boost after breast conserving surgery for breast cancer

Prospective randomized controlled clinical study of hypofractionated whole breast irradiation following simultaneous integrated boost / sequential boost after breast conserving surgery for breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099223
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Breast cancer

Interventions

Control group:Hypofractionated whole breast irradiation-sequential boost (HF-WBI-SB) : Hypofractionated whole breast irradiation 40~42.5Gy/15~16 fractions, sequential boost 8.7~10Gy/3~4 fractions.
Research group:Hypofractionated whole breast irradiation-simultaneous integrated boost (HF-WBI-SIB) : Hypofractionated whole breast irradiation 40~42.5Gy/15~16 fractions, simultaneous integrated boost

Sponsors

China-Japan Union Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women >=18 years old, life expectancy > 5 years; 2. Radiotherapy was started within 12 weeks after breast-conserving surgery (or 8 weeks from the end of chemotherapy); 3. Invasive ductal carcinoma, or mucinous carcinoma, papillary carcinoma, tubular carcinoma, medullary carcinoma; 4. Stage T1-3N0-1M0; 5. Having at least one of the following indicators: 18~49 years old; Maximum diameter > 2 cm (direct surgery) or T any size (after neoadjuvant therapy); Level III; The incisal margin was negative but the width was < 5 mm (except the basal incisal margin at the deep fascia); Hemangioma thrombus positive; Axillary lymph nodes were positive; 6. Single foci (MRI or PET-CT diagnosis); 7. Pathological margin was negative; 8. Can identify the primary tumor area, it is best to place metal markers on the tumor bed; 9. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Stage IV; 2. Multiple primary tumors; 3. lobular carcinoma in situ, invasive lobular carcinoma, EIC+ (extensive intraductal carcinoma component); 4. Simple papillary paget's disease; 5. History of ipsilateral chest wall radiotherapy; 6. Active collagen vascular disease.

Design outcomes

Primary

MeasureTime frame
5-year local + axillary recurrence rate;—

Secondary

MeasureTime frame
Incidence of acute and late adverse reactions;Remote transfer rate;Disease free survival;Overall survival;Living quality;Cosmetic breast effects;—

Countries

China

Contacts

Public ContactNing Wu

China-Japan Union Hospital of Jilin University

wuning@jlu.edu.cn+86 135 0433 4509

Outcome results

None listed

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