Shandong Cancer Hospital Affiliated to Shandong University

Shandong Cancer Hospital and Institute100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Early-stage Breast Cancer Breast Conserving Surgery

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 2 Weeks after the end of radiotherapy.

Secondary Outcomes

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

Time frame: 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.

Time frame: 6 months after radiotherapy

Degree of chronic skin toxicity and cosmesis after radiotherapy

Time frame: 2 years after radiotherapy

Degree of chronic skin toxicity and cosmesis after radiotherapy

Time frame: 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.

Time frame: From date of randomization until 60 months after the end of radiotherapy of last patients

Shandong Cancer Hospital Affiliated to Shandong University

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts