Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery

NCT ID: NCT02617043

Last Updated: 2017-05-02

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-31

Brief Summary

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The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.

Detailed Description

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Conditions

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Breast Cancer

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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HF-WBI

Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy.

Group Type EXPERIMENTAL

hypofractionated whole breast irradiation with simultaneously integrated boost

Intervention Type RADIATION

deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed

Interventions

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hypofractionated whole breast irradiation with simultaneously integrated boost

deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Female
* 18-60 years old
* Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
* Pathologically confirmed invasive breast cancer
* A pathological T1-2N0M0 tumor
* Tumor bed is labeled with Titanium clips
* Negative surgical margins
* Written informed consent.

Exclusion Criteria

* KPS\<70
* Treated with neoadjuvant chemotherapy
* Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm)
* With severe comorbidity
* Previous breast cancer or other malignant tumor history
* Previous radiotherapy for breast or thorax
* Medical contraindication for radiotherapy
* Pregnant or nursing
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xiaoli Yu

Associate Professor of department of radiation oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoli Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoli Yu, MD

Role: CONTACT

+86 13817893133

Facility Contacts

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Xiaoli Yu, MD,PhD

Role: primary

+86 13817893133

Jurui Luo, MD

Role: backup

+86 13162996951

Other Identifiers

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FDRT-BC001

Identifier Type: -

Identifier Source: org_study_id

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