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A prospective, randomized, parallel-group phase III clinical study of hypofractionated radiotherapy versus conventional fractionated radiotherapy for breast cancer patients after modified radical mastectomy

A prospective, randomized, parallel-group phase III clinical study of hypofractionated radiotherapy versus conventional fractionated radiotherapy for breast cancer patients after modified radical mastectomy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17011852
Enrollment
Unknown
Registered
2017-07-04
Start date
2017-07-01
Completion date
Unknown
Last updated
2017-07-10

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 with 40.05Gy/15F
Control group:Conventional fractionated radiotherapy 50Gy/25F

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 modified radical mastectomy surgery; 4. Disease stage were T1-3N1-2M0; 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. Person who does not meet the inclusion criteria; 2. Women who are pregnant; 3. The patient had mental disease; 4. history of radiation treatment in chest; 5. History of vascular collagen disease.

Design outcomes

Primary

MeasureTime frame
Breast cancer recurrence;Local control rate;

Secondary

MeasureTime frame
Overall survival;Recurrence free survival;Distant metastasis free survival;

Countries

China

Contacts

Public ContactWei Shihong

Gansu Cancer Hospital

weishihong100@163.com+86 13919252973

Outcome results

None listed

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