Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
Phase 3
Terminated
- Conditions
- Breast Cancer
- Interventions
- Radiation: radiationRadiation: no radiation
- Registration Number
- NCT00805597
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief Summary
The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description radiotherapy radiation radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region no radiotherapy no radiation no radiotherapy
- Primary Outcome Measures
Name Time Method overall survival 10 years
- Secondary Outcome Measures
Name Time Method loco-regional recurrence 5 years
Trial Locations
- Locations (1)
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China