Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

NCT ID: NCT04913532

Last Updated: 2026-01-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-22

Study Completion Date

2025-07-31

Brief Summary

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Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.

Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.

Detailed Description

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Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)

Conditions

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Breast Cancer Surgery Adjuvant Radiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypofractionation with SIB

Hypofractionation with SIB

Group Type EXPERIMENTAL

Hypofractionation with simultaneous integrated boost

Intervention Type RADIATION

Hypofractionation with simultaneous integrated boost

Interventions

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Hypofractionation with simultaneous integrated boost

Hypofractionation with simultaneous integrated boost

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
* 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

* Patients operated by mastectomy
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wenjie Ni

Capital Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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2020-q12

Identifier Type: -

Identifier Source: org_study_id

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