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Shandong Cancer Hospital Affiliated to Shandong University

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ClinicalTrials.gov Identifier: NCT02958033
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Min Xu, Shandong Cancer Hospital and Institute

Study Description
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Brief Summary:
In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.

Condition or disease Intervention/treatment Phase
Early-stage Breast Cancer Breast Conserving Surgery Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shandong Cancer Hospital Affiliated to Shandong University
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HF WBI-SIB breast radiation
WBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18)
 Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost
hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group
Placebo Comparator: CF WBI-SIB breast radiation
WBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28)
 Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost
hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group


Outcome Measures
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Primary Outcome Measures :
  1. Degree of acute skin toxicity [ Time Frame: 2 Weeks after the end of radiotherapy. ]
    To determine the acute toxicity of accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost


Secondary Outcome Measures :
  1. local control [ Time Frame: From data of randomization until 60 months after the end of radiotherapy of last patients ]
    To determine the local control in women with early stage breast cancer treated with accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost

  2. Degree of chronic skin toxicity and cosmesis after radiotherapy [ Time Frame: 6 months after radiotherapy ]
    To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.

  3. Degree of chronic skin toxicity and cosmesis after radiotherapy [ Time Frame: 2 years after radiotherapy ]
    To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.

  4. Degree of chronic skin toxicity and cosmesis after radiotherapy [ Time Frame: 5 years after radiotherapy ]
    To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.

  5. overall survival [ Time Frame: From date of randomization until 60 months after the end of radiotherapy of last patients ]
    To determine whether the overall survival after hypo-fractionated breast radiation with concurrent boost is non-inferior to conventional fractionated radiation therapy with concurrent boost.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients has had breast conserving surgery
  2. age ≥ 18 and ≤ 65 years
  3. with a histological diagnosis of invasive carcinoma of the breast
  4. with pathological stage of T1-2N0-1M0
  5. multidisciplinary decision of adjuvant WBI with a boost to the tumor bed
  6. informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

  1. patients treated with Mastectomy
  2. Need for lymph node irradiation
  3. positive or close(≤ 1 mm) surgical margin
  4. treated with neoadjuvant chemotherapy before surgery
  5. Bilateral malignancy of the breast (synchronous or metachronous)
  6. Pregnant or breastfeeding
  7. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
  8. Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
Contacts and Locations
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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): NCT02958033


Contacts
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Contact: Min Xu +86-531-67626132 xumin7799@sina.com

Locations
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China, Shandong
Jiyan Road No.440 Recruiting
Jinan, Shandong, China, 250117
Contact: Min Xu    +86-531-67626132    xumin7799@sina.com   
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
More Information
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Responsible Party: Min Xu, Principal Investigator, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT02958033    
Other Study ID Numbers: Shandong Cancer Hospital
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided