Shandong Cancer Hospital Affiliated to Shandong University

November 4, 2016 updated by: Min Xu, Shandong Cancer Hospital and Institute
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Jiyan Road No.440
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Degree of acute skin toxicity
Time Frame: 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
2 Weeks after the end of radiotherapy.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
local control
Time Frame: 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
From data of randomization until 60 months after the end of radiotherapy of last patients
Degree of chronic skin toxicity and cosmesis after radiotherapy
Time Frame: 6 months 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
Time Frame: 2 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.
2 years after radiotherapy
Degree of chronic skin toxicity and cosmesis after radiotherapy
Time Frame: 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.
5 years after radiotherapy
overall survival
Time Frame: 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.
From date of randomization until 60 months after the end of radiotherapy of last patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shandong Cancer Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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