Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery (HF-WBI-SIB)

May 1, 2017 updated by: Xiaoli Yu, Fudan University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost
deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
Time Frame: 2 year
acute toxicity related to irradiation such as lung and skin
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 5 years
5 years
acute radiation-induced toxicity assessed by CTCAE v4.0
Time Frame: during radiotherapy; 3months; 6 months
acute toxicity related to skin and lung
during radiotherapy; 3months; 6 months
local-regional recurrence
Time Frame: 5 years
5 years
Overall survival Over survival
Time Frame: 5 years
5 years
Late complications
Time Frame: 1,2,3,4,5years
1,2,3,4,5years
cosmetic effect measured by Harvard 4 scale evaluation system
Time Frame: 2,3,4,5years
2,3,4,5years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xiaoli Yu, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-BC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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