Breast CancerNCT04025164
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
A study testing Hypofractionated Radiotherapy and Conventional fractionated Radiotherapy in people with Breast Cancer, run by Fudan University at 5 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hypofractionated Radiotherapy and Conventional fractionated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,052 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jul 2018to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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
Who cannot join
- T4 or M1 breast cancer
- Supraclavicular or internal mammary nodes metastases
- Pathologically confirmed DCIS only without an invasive component
- Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
- Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy
- Multiple lesions can not be removed by single quadrantectomy
Show all 15Show fewer
- Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast)
- KPS ≤ 70
- Patients with severe non-malignant comorbidity in cardiovascular or respiration system
- Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
- Previous radiotherapy to the chest wall or regional lymph node areas
- Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
- Pregnant or lactating
- Conditions indicating that the patient cannot go through the radiation therapy or follow up
- Unable or unwilling to sign informed consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116044
Yanqin Yang, PhD, 17709870293, yqtoday2008@126.com
- Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Xin Li, PhD, 13984157730, 315332722@qq.com
- Recruiting
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, 200002
Gang Chen, 021-63212487, fodeng73@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaoli Yu, MD,PhD, +86-13817893133, stephanieyxl@hotmail.com
Jurui Luo, PhD, +86-13162996951, juruiluo@hotmail.com
- Recruiting
Suzhou Municipal hospital
Suzhou, Jiangsu, 215000
Qunchao Hu, PhD, +86-17712679728, hqc82@163.com
About this study
Official title: Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial
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
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Hypofractionated Radiotherapy, Conventional fractionated Radiotherapy
- Keywords
- Hypofractionated radiotherapy, Breast Conserving Surery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated RadiotherapyRadiation
Also called Experimental Arm
daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
Conventional fractionated RadiotherapyRadiation
Also called Standard Arm
daily fractions, 2 Gy per fraction, five fractions per week
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiotherapy | Experimental | 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. Receives: Radiation: Hypofractionated Radiotherapy |
| Conventional Irradiation | Active comparator | 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. Receives: Radiation: Conventional fractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco-regional recurrence (LRR)
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).
Measured: 5 years
Secondary outcomes (10)
Distant metastasis free survival (DMFS)
Distant metastasis is defined as clinical detection of metastatic disease beyond the chest wall and/or regional lymph nodes or death or last visit. Distant metastasis free survival (DMFS) is defined as the interval starting from the date of randomization until to the event.
Measured: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Disease free survival (DFS)
Defined as the interval from the date of randomization to any disease recurrence or death or last visit.
Measured: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Overall survival (OS)
Defined as the interval from the date of randomization to death or last visit.
Measured: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Number of patients with radiation-induced acute toxicity assesses by CTCAE4.03
Acute toxicity (development of radiation dermatitis, pruritus, pain, radiation esophagitis, and radiation pneumonitis) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment, during treatment (after 8 fractions irradiation for HF-RTgroup and 15 fractions for CF-RT group) and the end of treatment (15 fractions irradiation for HF-RTgroup and 30 fractions for CF-RT group), 2 weeks and 3 months after the last fraction received.
Measured: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation, 2 weeks and 3 months after the irradiation finished
Number of patients with radiation-induced late toxicity assesses by CTCAE4.03
Late toxicity (change of skin in irradiated area，impaired shoulder movement ，impaired shoulder movement, brachial plexopathy,ischemic heart disease) will be assessed according to toxicity criteria of CTCAE version 4.03
Measured: before treatment, every year after the last fraction received through 10 years
Number of patients with radiation-induced late toxicity assesses by LENT-SOMA Toxicity Assessment
Development of dyspigmentation, telangiectasia in irradiated area and radiation pulmonary fibrosis will be assessed according to toxicity criteria of LENT-SOMA
Measured: before treatment, every year after the last fraction received through 10 years
Harvard/NSABP/RTOG Breast Cosmesis Grades of patients
The cosmetic outcomes will be evaluated by radiation oncologists, nurses and patients using digital photographs and Harvard/NSABP/RTOG Breast Cosmesis Grading Scale. Harvard/NSABP/RTOG Breast Cosmesis Grading Scale classifies the overall aesthetic results in four categories from excellent, good, fair to poor.
Measured: before treatment, every year after the last fraction received through 10 years
Quality of Life Score assessed by EORTC-QLQ-C30 (version 3)
Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3)
Measured: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation，every year after the treatment finished through 10 years
Quality of Life Score assessed by EORTC breast-cancer module (BR23)
Patients' quality of life will be assessed using self-administered questionnaire EORTC breast-cancer module (BR23)
Measured: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation, every year after the last fraction received through 10 years
Number and percentage of peripheral blood lymphocytes
peripheral blood lymphocytes will be assessed before, during treatment (after 8 fractions irradiation for HF-RTgroup and 15 fractions for CF-RT group) and the end of treatment (15 fractions irradiation for HF-RTgroup and 30 fractions for CF-RT group). The number and percentage of peripheral blood lymphocytes will be assessed the correlation with the grade of acute toxicity assessed by CTCAE 4.03
Measured: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Jul 2018
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,052 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Yu, Fudan University
- Investigators
- Xiaoli Yu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025164
- Sponsor's protocol ID
- FDRT-BC007
- Status last verified
- Jul 2019
- First submitted
- 6 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jin K, Luo J, Yu X, Guo X. Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial. Radiat Oncol. 2024 May 27;19(1):62. doi: 10.1186/s13014-024-02449-y.
PubMed 38802888
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04025164
- Acronym / sponsor ID
- FDRT-BC007
- Conditions
- Breast Cancer
- Keywords
- Hypofractionated radiotherapy, Breast Conserving Surery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,052 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiotherapy | Experimental | Radiation: Hypofractionated Radiotherapy40 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. |
| Conventional Irradiation | Active comparator | Radiation: Conventional fractionated Radiotherapy50 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (15 listed)
- T4 or M1 breast cancer
- Supraclavicular or internal mammary nodes metastases
- Pathologically confirmed DCIS only without an invasive component
- Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
- Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated RadiotherapyAlso: Experimental Armdaily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week | Radiation | Hypofractionated Radiotherapy |
| Conventional fractionated RadiotherapyAlso: Standard Armdaily fractions, 2 Gy per fraction, five fractions per week | Radiation | Conventional Irradiation |
Primary outcome
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).
10 secondary outcomes
Distant metastasis free survival (DMFS)
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Disease free survival (DFS)
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Overall survival (OS)
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Number of patients with radiation-induced acute toxicity assesses by CTCAE4.03
Time frame: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation, 2 weeks and 3 months after the irradiation finished
Number of patients with radiation-induced late toxicity assesses by CTCAE4.03
Time frame: before treatment, every year after the last fraction received through 10 years
Number of patients with radiation-induced late toxicity assesses by LENT-SOMA Toxicity Assessment
Time frame: before treatment, every year after the last fraction received through 10 years
Harvard/NSABP/RTOG Breast Cosmesis Grades of patients
Time frame: before treatment, every year after the last fraction received through 10 years
Quality of Life Score assessed by EORTC-QLQ-C30 (version 3)
Time frame: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation，every year after the treatment finished through 10 years
Quality of Life Score assessed by EORTC breast-cancer module (BR23)
Time frame: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation, every year after the last fraction received through 10 years
Number and percentage of peripheral blood lymphocytes
Time frame: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 38802888Jin K, Luo J, Yu X, Guo X. Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial. Radiat Oncol. 2024 May 27;19(1):62. doi: 10.1186/s13014-024-02449-y.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoli Yu, MD, PhD principal investigator
Fudan University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiotherapy and Conventional fractionated Radiotherapy in people with Breast Cancer, run by Fudan University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Yu, MD, PhD (+86-13817893133, stephanieyxl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loco-regional recurrence (LRR) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.