Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Radiation: Hypofractionated Radiotherapy Radiation: Conventional fractionated Radiotherapy | Not Applicable |
Eligible patients after breast conserving surgery will be randomized 1:1 into hypofractionated radiotherapy (HF-RT) group or conventionally fractionated radiotherapy (CF-RT) group.
Patients in HF-RT group will receive 40 Gy/15 fractions irradiation to the whole breast with/without regional lymphnodes within 3 weeks and the tumor bed is boosted to 48 Gy/15 fractions simutaneously.
Patients in CF-RT group will receive 50 Gy/ 25 fractions irradiation to whole breast with/without regional lymphnodes within 5 weeks and the tumor bed is boosted to 60 Gy/30 fractions sequentially.
The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.
It is hypothesized that hypofractionated radiotherapy is non inferior to conventional fractionated radiotherapy in terms of tumor loco-regional control for patients after breast conserving surgery.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 4052 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery:a Multi-center Phase III Randomized Clinical Trial |
Actual Study Start Date : | July 1, 2018 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | June 30, 2028 |
Arm | Intervention/treatment |
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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. |
Radiation: Hypofractionated Radiotherapy
daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
Other Name: Experimental Arm
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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. |
Radiation: Conventional fractionated Radiotherapy
daily fractions, 2 Gy per fraction, five fractions per week
Other Name: Standard Arm
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xiaoli Yu, MD, PhD | +86-13817893133 | stephanieyxl@hotmail.com | |
Contact: Jurui Luo, PhD | +86-13162996951 | juruiluo@hotmail.com |
China, Guizhou | |
Guizhou Provincial People's Hospital | Not yet recruiting |
Guiyang, Guizhou, China, 550002 | |
Contact: Xin Li, PhD 13984157730 315332722@qq.com | |
China, Jiangsu | |
Suzhou Municipal hospital | Recruiting |
Suzhou, Jiangsu, China, 215000 | |
Contact: Qunchao Hu, PhD +86-17712679728 hqc82@163.com | |
China, Liaoning | |
The Second Hospital of Dalian Medical University | Not yet recruiting |
Dalian, Liaoning, China, 116044 | |
Contact: Yanqin Yang, PhD 17709870293 yqtoday2008@126.com | |
China, Shanghai | |
Shanghai Huangpu District Central Hospital | Recruiting |
Shanghai, Shanghai, China, 200002 | |
Contact: Gang Chen 021-63212487 fodeng73@163.com | |
Fudan University Shanghai Cancer Center | Recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Xiaoli Yu, MD,PhD +86-13817893133 stephanieyxl@hotmail.com | |
Contact: Jurui Luo, PhD +86-13162996951 juruiluo@hotmail.com |
Principal Investigator: | Xiaoli Yu, MD, PhD | Fudan University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 6, 2019 | ||||||||
First Posted Date ICMJE | July 18, 2019 | ||||||||
Last Update Posted Date | July 18, 2019 | ||||||||
Actual Study Start Date ICMJE | July 1, 2018 | ||||||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Loco-regional recurrence (LRR) [ Time Frame: 5 years ] Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery | ||||||||
Official Title ICMJE | Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery:a Multi-center Phase III Randomized Clinical Trial | ||||||||
Brief 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 | ||||||||
Detailed Description |
Eligible patients after breast conserving surgery will be randomized 1:1 into hypofractionated radiotherapy (HF-RT) group or conventionally fractionated radiotherapy (CF-RT) group. Patients in HF-RT group will receive 40 Gy/15 fractions irradiation to the whole breast with/without regional lymphnodes within 3 weeks and the tumor bed is boosted to 48 Gy/15 fractions simutaneously. Patients in CF-RT group will receive 50 Gy/ 25 fractions irradiation to whole breast with/without regional lymphnodes within 5 weeks and the tumor bed is boosted to 60 Gy/30 fractions sequentially. The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years. It is hypothesized that hypofractionated radiotherapy is non inferior to conventional fractionated radiotherapy in terms of tumor loco-regional control for patients after breast conserving surgery. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
4052 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 30, 2028 | ||||||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04025164 | ||||||||
Other Study ID Numbers ICMJE | FDRT-BC007 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Xiaoli Yu, Fudan University | ||||||||
Study Sponsor ICMJE | Fudan University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Fudan University | ||||||||
Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |