Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
NCT ID: NCT04913532
Last Updated: 2026-01-23
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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COMPLETED
NA
35 participants
INTERVENTIONAL
2021-06-22
2025-07-31
Brief Summary
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Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypofractionation with SIB
Hypofractionation with SIB
Hypofractionation with simultaneous integrated boost
Hypofractionation with simultaneous integrated boost
Interventions
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Hypofractionation with simultaneous integrated boost
Hypofractionation with simultaneous integrated boost
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Wenjie Ni
Capital Medical University
Principal Investigators
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Wenjie Ni, MD.
Role: PRINCIPAL_INVESTIGATOR
Beijing Shijitan Hospital, Capital Medical University
Locations
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Beijing Shijitan Hospital
Beijing, , China
Countries
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Other Identifiers
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2020-q12
Identifier Type: -
Identifier Source: org_study_id
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