Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer
NCT ID: NCT03856372
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1494 participants
INTERVENTIONAL
2018-09-01
2028-10-30
Brief Summary
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Detailed Description
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Eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly.
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 for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypofractionated
42.5 Gy / 16 fractions, 2.66 Gy per fraction, 5 fractions weekly
Hypofractionated
daily fractions, five fractions per week.
Conventional
50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly
Conventional
daily fractions, five fractions per week.
Interventions
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Hypofractionated
daily fractions, five fractions per week.
Conventional
daily fractions, five fractions per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age18-75 years
* Pathologically confirmed invasive breast cancer
* Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
* Negative surgical margins
* Pathologic T1-2N1 with at least one of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
* No distant metastases
* No supraclavicular or internal mammary nodes metastases
* ECOG:0-1
* Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
* No neoadjuvant chemotherapy
* Fit for postoperative radiotherapy. No contraindications to radiotherapy
* Signed informed consent
Exclusion Criteria
* Previous radiotherapy to the chest wall or regional lymph node areas
* Patients with severe non-malignant comorbidity in cardiovascular or respiration system
* Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
* pT1-2N1 with none of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
* Patients with supraclavicular or internal mammary nodes metastases
* Known definitive clinical or radiologic evidence of metastatic disease
* Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
* Treated with neoadjuvant chemotherapy
* ECOG: 3-4
* Pregnant or lactating
* Conditions indicating that the patient cannot go through the radiation therapy or follow up
* Unable or unwilling to sign informed consent
18 Years
75 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Jinli Ma
Associate Professor of department of radiation oncology
Principal Investigators
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Jinli Ma, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Suzhou Municipal hospital
Suzhou, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Huangpu Branch, Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qunchao Hu, MD, PhD
Role: primary
Jinli Ma, MD, PhD
Role: primary
Gang Chen, MD
Role: primary
Other Identifiers
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FDRT-BC008
Identifier Type: -
Identifier Source: org_study_id
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