Shandong Cancer Hospital Affiliated to Shandong University

NCT02958033 | Unknown Phase 3 DMC

• 1 other identifier: Shandong Cancer Hospital
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-stage Breast Cancer; Breast Conserving Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• local control

  From data of randomization until 60 months after the end of radiotherapy of last patients

• Degree of chronic skin toxicity and cosmesis after radiotherapy

  6 months after radiotherapy

• Degree of chronic skin toxicity and cosmesis after radiotherapy

  2 years after radiotherapy

• Degree of chronic skin toxicity and cosmesis after radiotherapy

  5 years after radiotherapy

• overall survival

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

Study Arms (2)

HF WBI-SIB breast radiation

EXPERIMENTAL

WBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18)

Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost

CF WBI-SIB breast radiation

PLACEBO COMPARATOR

WBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28)

Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost

Interventions

Whole Breast irradiation Plus simultaneous tumor bed Boost RADIATION

hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group

CF WBI-SIB breast radiation; HF WBI-SIB breast radiation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Jiyan Road No.440

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Min Xu

CONTACT

+86-531-67626132; xumin7799@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2024
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

CN (1)