Breast Cancer Clinical Trial
Official title:
Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial
The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy
The randomization is between 50 Gy / 25 fractions and 42.5 Gy/16 fractions, 5 fractions
weekly.
Eligible breast cancer patients with mastectomy and axillary dissection will be randomized
1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and
hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly.
The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late
radiation morbidities will also be evaluated. The patients will be followed for 10 years.
It is hypothesized that for women operated for high risk breast cancer with indication of
postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to
conventional fractionated radiotherapy in terms of the efficacy and toxicities.
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| NCT number | NCT03856372 |
| Study type | Interventional |
| Source | Fudan University |
| Contact | Jinli Ma, MD, PhD |
| Phone | +86-15221033376 |
| [email protected] | |
| Status | Recruiting |
| Phase | N/A |
| Start date | September 1, 2018 |
| Completion date | October 30, 2028 |
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