Shandong Cancer Hospital Affiliated to Shandong University

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.

Study Overview

• Status: Recruiting
• Conditions: Early-stage Breast Cancer; Breast Conserving Surgery
• Intervention / Treatment: Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Min Xu; Phone Number: +86-531-67626132; Email: xumin7799@sina.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Jiyan Road No.440
      • Contact: Min Xu; Phone Number: +86-531-67626132; Email: xumin7799@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of acute skin toxicity	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	2 Weeks after the end of radiotherapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local control	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	From data of randomization until 60 months after the end of radiotherapy of last patients
Degree of chronic skin toxicity and cosmesis 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.	6 months after radiotherapy
Degree of chronic skin toxicity and cosmesis 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.	2 years after radiotherapy
Degree of chronic skin toxicity and cosmesis 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 years after radiotherapy
overall survival	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.	From date of randomization until 60 months after the end of radiotherapy of last patients

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): November 1, 2024

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (ESTIMATE): November 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Shandong Cancer Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED