Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery

November 27, 2015 updated by: Xiaoli Yu, Fudan University

Phase II Study of Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery

This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized clinical trials have demonstrated that the recurrence of DCIS is low and most of the recurrence occurs around the tumor bed. Besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. However, whether or not partial breast irradiation is safety in DCIS is still unknown. The purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Study Type

Observational

Enrollment (Anticipated)

828

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • 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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

DCIS breast cancer patients

Description

Inclusion Criteria:

  • Female
  • 18~65 years old
  • Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3)
  • Treated with breast conserving surgery
  • Tumor bed is labeled with Titanium clips
  • No malignancy history
  • ECOG score 0~1
  • Written informed consent

Exclusion Criteria:

  • DCIS of both breast
  • invasive breast cancer
  • Multicentric disease
  • Patients underwent mastectomy
  • Previous radiation therapy of breast
  • Medical contraindication for radiotherapy
  • Pregnant or nursing
  • suspicious calcification after surgery

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
partial breast irradiation
Radiation: partial breast irradiation
The prescription dose is 40.5Gy in 15 fractions in 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ipsilateral breast tumor recurrence
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years
Disease free survival
Time Frame: 5 years
5 years
occurrence of contralateral breast tumor after PBI
Time Frame: 5 years
5 years
radiation-induced toxicity of breast assessed by CTCAE v4.0
Time Frame: baseline, 3 months, 6 months, and every half year to 5 years
baseline, 3 months, 6 months, and every half year to 5 years
Complications
Time Frame: baseline，1，2，3，4，5 years
baseline，1，2，3，4，5 years

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xiaoli Yu, MD.PhD, Fudan University

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

October 1, 2015

Primary Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

November 21, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 27, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-BC004

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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