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

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ClinicalTrials.gov Identifier: NCT02617043
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaoli Yu, Fudan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
Study Start Date : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. acute radiation-induced toxicity assessed by CTCAE v4.0 [ Time Frame: during radiotherapy; 3months; 6 months ]
    acute toxicity related to skin and lung

  2. local-regional recurrence [ Time Frame: 5 years ]
  3. Disease free survival [ Time Frame: 5 years ]
  4. Overall survival Over survival [ Time Frame: 5 years ]
  5. Late complications [ Time Frame: 1,2,3,4,5years ]
  6. cosmetic effect measured by Harvard 4 scale evaluation system [ Time Frame: 2,3,4,5years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617043


Contacts
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Contact: Xiaoli Yu, MD +86 13817893133 stephanieyxl@hotmail.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaoli Yu, MD,PhD    +86 13817893133    stephanieyxl@hotmail.com   
Contact: Jurui Luo, MD    +86 13162996951    juruiluo@hotmail.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xiaoli Yu, MD Fudan University

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Responsible Party: Xiaoli Yu, Associate Professor of department of radiation oncology, Fudan University
ClinicalTrials.gov Identifier: NCT02617043     History of Changes
Other Study ID Numbers: FDRT-BC001
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by Xiaoli Yu, Fudan University:
breast cancer
hypofractionated whole breast irradiation

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases