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Hypofractionated radiotherapy versus conventional fractionated radiotherapy for breast cancer patients after breast-conserving surgery: a prospective, randomized, parallel-group phase III clinical study

Hypofractionated radiotherapy versus conventional fractionated radiotherapy for breast cancer patients after breast-conserving surgery: a prospective, randomized, parallel-group phase III clinical study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014335
Enrollment
Unknown
Registered
2018-01-06
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-01-08

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

Conditions

Breast Cancer

Interventions

Study group:Hypofractional radiotherapy, 40.05Gy/15F to the whole breast,48.75Gy/15F to tumor bed
Control group:Conventional fractionated radiotherapy, 50.4Gy/28F to the whole breast, 61.6Gy/28F to tumor bed

Sponsors

Gansu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Women aged between 40 and 75 years old, ECOC 0-2 or KPS =70; 2. pathologically diagnosed with invasive breast cancer patients; 3. Treated with breast-conserving surgery and with negative margins; 4. Disease stage were pTis-2N0-1M0;5.The time of radiotherapy to operation less than 42 weeks; 5. no major organ dysfunction, blood, lung, liver, kidney and heart function are normal; 6. patients have good compliance to treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant; 2. The patient had mental disease; 3. history of radiation treatment in chest; 4. History of vascular collagen disease; 5. Patients accepted breast-conserving surgery and breast reconstruction at the same time; 6. The surgical cavity without be denoted by silver clips.

Design outcomes

Primary

MeasureTime frame
Breast cancer recurrence;Local control rate;Local control rate;

Secondary

MeasureTime frame
Local control rate;Recurrence free survival;Distant metastasis free survival;

Countries

China

Contacts

Public ContactWei Shihong

Gansu Cancer Hospital

weishhong100@163.com+86 13919252973

Outcome results

None listed

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