NCT02389699

Brief Summary

Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to compare the effectiveness of radiation therapy during surgery and whole-breast radiation therapy in treating women who have undergone breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

March 10, 2015

Last Update Submit

March 10, 2015

Conditions

Breast Neoplasms

Keywords

Intermediate and high grade ductal carcinoma in situ （DCIS）

Outcome Measures

Primary Outcomes (2)

  • ipsilateral breast tumor recurrence rate after surgery within five years

    Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure

    Within 5 years after surgery

  • Disease free survival after surgery within five years

    Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure.

    Within 5 years after surgery

Secondary Outcomes (1)

  • Overall survival after surgery within ten years

    Within ten years after surgery

Study Arms (2)

Intraoperative Radiotherapy

EXPERIMENTAL

Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Radiation: Intraoperative Radiotherapy

whole breast radiation

ACTIVE COMPARATOR

WRT:whole breast radiation after BCS with 46-50 Gy

Radiation: Whole breast radiation

Interventions

Intraoperative RadiotherapyRADIATION

Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Intraoperative Radiotherapy
Whole breast radiationRADIATION

whole breast radiation after BCS with 46-50 Gy

whole breast radiation

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tumor diameter \< 5 cm
  • Intermediate or high grade ductal carcinoma in situ
  • Informed consent

You may not qualify if:

  • No informed consent
  • Tumor size \> 3,5 cm
  • Low grade ductal carcinoma in situ
  • Invasive carcinoma
  • No indication for a boost

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Liao Ning, MD,PhD

    Guangdong Academy of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Guangdong Academy of Medical Sciences

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 17, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2024

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

CN(1)