Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes|
- overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- loco-regional recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region
radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
Active Comparator: no radiotherapy
Radiation: no radiation
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.
|Cancer Hospital, Chinese Academy of Medical Sciences|
|Beijing, China, 100021|
|Study Chair:||Ye-xiong Li, M.D.||Cancer Hospital, Chinese Academy of Medical Sciences|