Status:
ACTIVE_NOT_RECRUITING
Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Lead Sponsor:
Capital Medical University
Conditions:
Breast Cancer
Surgery
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been in...
Detailed Description
Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)
Eligibility Criteria
Inclusion
- Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
- Indication to adjuvant radiotherapy including boost radiotherapy
- Clearly identified primary tumor region preferably by radiopaque clips
- Primary wound healing after breast conserving therapy without signs of infection
- Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
- Written informed consent
Exclusion
- Patients operated by mastectomy
- No indication for boost radiation
- Resection margins positive for disease or insufficient identification of the boost volume
- Indication for radiotherapy of the regional lymph nodes
- History of prior breast or thoracic radiotherapy
- Extended postoperative seroma at the beginning of radiotherapy
- Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
- Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04913532
Start Date
June 22 2021
End Date
July 31 2025
Last Update
April 30 2024
Active Locations (1)
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1
Beijing Shijitan Hospital
Beijing, China, 100038