Status:
RECRUITING
Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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 ri...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Female
- Age18-75 years
- Pathologically confirmed invasive breast cancer
- Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
- Negative surgical margins
- Pathologic T1-2N1 with at least one of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
- No distant metastases
- No supraclavicular or internal mammary nodes metastases
- ECOG:0-1
- Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
- No neoadjuvant chemotherapy
- Fit for postoperative radiotherapy. No contraindications to radiotherapy
- Signed informed consent
Exclusion
- Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
- Previous radiotherapy to the chest wall or regional lymph node areas
- Patients with severe non-malignant comorbidity in cardiovascular or respiration system
- Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
- pT1-2N1 with none of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
- Patients with supraclavicular or internal mammary nodes metastases
- Known definitive clinical or radiologic evidence of metastatic disease
- Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
- Treated with neoadjuvant chemotherapy
- ECOG: 3-4
- Pregnant or lactating
- Conditions indicating that the patient cannot go through the radiation therapy or follow up
- Unable or unwilling to sign informed consent
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
1494 Patients enrolled
Trial Details
Trial ID
NCT03856372
Start Date
September 1 2018
End Date
October 30 2028
Last Update
February 27 2019
Active Locations (3)
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1
Suzhou Municipal hospital
Suzhou, Jiangsu, China
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
3
Huangpu Branch, Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China