Shandong Cancer Hospital Affiliated to Shandong University

Phase 3

Recruiting

• Conditions: Early-stage Breast Cancer; Breast Conserving Surgery
• Interventions: Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost

• Registration Number: NCT02958033
• Lead Sponsor: Shandong Cancer Hospital and Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-18
• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-04
• Last Update Submitted: 2016-11-04
• Study First Posted: 2016-11-08
• Last Update Posted: 2016-11-08
• Primary Completion: 2019-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CF WBI-SIB breast radiation	Whole Breast irradiation Plus simultaneous tumor bed Boost	WBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28)
HF WBI-SIB breast radiation	Whole Breast irradiation Plus simultaneous tumor bed Boost	WBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18)

Primary Outcome Measures

Name	Time	Method
Degree of acute skin toxicity	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

Name	Time	Method
local control	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
Degree of chronic skin toxicity and cosmesis after radiotherapy	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.
overall survival	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.

Trial Locations

Locations (1)

Jiyan Road No.440; 🇨🇳 Jinan, Shandong, China