Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery:a Multi-center Phase III Randomized Clinical Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Female

• Age18-70 years

• Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy

• Receive breast conserving surgery with negative margins

• Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed.

• The tumor bed is labeled with clips and it can be drawn on the treatment planning system.

• Pathologically confirmed invasive breast cancer

• Pathologically stage is T1-3N0-3M0

• Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery

• No distant metastases

• No supraclavicular or internal mammary nodes metastases

• No neoadjuvant chemotherapy

• Fit for postoperative radiotherapy. No contraindications to radiotherapy

• KPS≥80

• Signed informed consent

Locations
Other Locations
China
The Second Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Shanghai Huangpu District Central Hospital
RECRUITING
Shanghai
Suzhou Municipal hospital
RECRUITING
Suzhou
Contact Information
Primary
Xiaoli Yu, MD, PhD
stephanieyxl@hotmail.com
+86-13817893133
Backup
Jurui Luo, PhD
juruiluo@hotmail.com
+86-13162996951
Time Frame
Start Date: 2018-07-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 4052
Treatments
Experimental: Hypofractionated Radiotherapy
40 Gy/15 fractions irradiation is delivered to the whole breast, 2.67 Gy per fraction, 5 fractions weekly.~Tumor bed is boosted to 48 Gy simultaneously, 3.2 Gy per fraction, 5 fractions weekly.
Active_comparator: Conventional Irradiation
50 Gy/25 fractions irradiation is delivered to the whole breast, 2 Gy per fraction, 5 fractions weekly.~Additional 10 Gy/5 fractions is boosted to tumor bed sequentially, 2 Gy per fraction, 5 fractions weekly.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov