Shandong Cancer Hospital Affiliated to Shandong University

Early-stage Breast Cancer Clinical Trial

Official title:

Shandong Cancer Hospital Affiliated to Shandong University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02958033
• Other study ID #: Shandong Cancer Hospital
• Status: Recruiting
• Phase: Phase 3
• First received: October 18, 2016
• Last updated: November 4, 2016
• Start date: November 2016
• Est. completion date: November 2024

Study information

• Verified date: November 2016
• Source: Shandong Cancer Hospital and Institute
• Contact: Min Xu
• Phone: +86-531-67626132
• Email: xumin7799[@]sina.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Shandong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Conserving Surgery
• Early-stage Breast Cancer

Intervention

Radiation:
• Whole Breast irradiation Plus simultaneous tumor bed Boost
hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group

Locations

Country	Name	City	State
China	Jiyan Road No.440	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes