Status:
UNKNOWN
Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
Lead Sponsor:
Ahmed Ahm
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 hypofractionated radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients treated with mastec...
Detailed Description
Eligible breast cancer patients with mastectomy and axillary dissection are divided into two groups: conventional fractionated (CF) radiotherapy of 50 Gray (GY) in 25 fractions within 5 weeks to ipsil...
Eligibility Criteria
Inclusion
- Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer
- Undergone total mastectomy and axillary dissection T 3-4 and/or 4 or more positive axillary lymph nodes.
- Fit for chemotherapy ( if indicated) , endocrine therapy (if indicated), and postoperative irradiation.
- Written informed concent.
- C T3-4 , or C N2, 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 did't receive neoadjuvant therapy.
- Enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and did'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
- Bilateral breast cancer.
- Immediate or delayed ipsilateral breast cancer reconstruction.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03319069
Start Date
October 1 2017
End Date
September 1 2019
Last Update
October 24 2017
Active Locations (1)
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1
Assiut faculty of medicine , clinical oncology and nuclear medicine department
Asyut, Egypt, 088