Status:
COMPLETED
Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionatio...
Eligibility Criteria
Inclusion
- KPS\>=60
- histology confirmed invasive breast cancer
- received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
- surgical margins negative
- primary tumor ≤5cm in the largest diameter
- no internal mammary node or supraclavicular node metastases or distant metastasis
- can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
- for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
- for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
- patients signed written inform consent form
Exclusion
- ductal carcinoma in situ
- prior neoadjuvant chemotherapy
- prior breast cancer history
- bilateral breast cancer
- pregnant or during lactation
- prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
- active collagen vascular disease
- prior neoadjuvant hormone therapy
- immediate ipsilateral breast reconstruction
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT01413269
Start Date
June 1 2010
End Date
September 1 2018
Last Update
October 11 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing hospital
Beijing, Beijing Municipality, China, 100730
2
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
3
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
4
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021