Status:
COMPLETED
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It ...
Detailed Description
Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral ches...
Eligibility Criteria
Inclusion
- Ipsilateral histologically confirmed invasive breast cancer
- Undergone total mastectomy and axillary dissection
- T3-4,or \>=4 positive axillary lymph nodes
- Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
- Written,informed consent
- cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
- no supraclavicular or internal mammary nodes metastases
- no distant metastases
- enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
- enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.
Exclusion
- Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
- Previous or concurrent malignant other than non-melanomatous skin cancer
- Unable or unwilling to give informed consent
- bilateral breast cancer
- immediate or delayed ipsilateral breast cancer reconstruction
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT00793962
Start Date
June 1 2008
End Date
September 1 2018
Last Update
October 11 2018
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021