A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
18 Years
75 Years
Female
Breast Cancer
Trial Information
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
Eligible breast cancer patients with mastectomy and axillary dissection are randomized into
2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and
supraclavicular nodal region,and no radiotherapy.
During and after radiotherapy, the patients are followed and the efficacy and toxicities of
radiotherapy are evaluated.
Inclusion Criteria:
- Ipsilateral histologically confirmed invasive breast cancer
- Undergone total mastectomy and axillary dissection
- T1-2 and one to three axillary lymph nodes positive
- A minimum of 10 axillary nodes dissected
- Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative
irradiation
- Written,informed consent
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
10 years
Safety Issue:
No
Principal Investigator
Ye-xiong Li, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Hospital, Chinese Academy of Medical Sciences
Authority:
China: Ethics Committee
Study ID:
LC2008B06
NCT ID:
NCT00805597
Start Date:
June 2008
Completion Date:
Related Keywords:
- Breast Cancer
- breast cancer
- mastectomy
- one to three positive nodes
- radiotherapy
- Breast Neoplasms
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