Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Ductal Carcinoma in Situ

NCT ID: NCT02389699

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intraoperative Radiotherapy

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

Group Type EXPERIMENTAL

Intraoperative Radiotherapy

Intervention Type RADIATION

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

whole breast radiation

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

Group Type ACTIVE_COMPARATOR

Whole breast radiation

Intervention Type RADIATION

whole breast radiation after BCS with 46-50 Gy

Interventions

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Intraoperative Radiotherapy

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

Intervention Type RADIATION

Whole breast radiation

whole breast radiation after BCS with 46-50 Gy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Liao Ning

OTHER

Sponsor Role lead

Responsible Party

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Liao Ning

Guangdong Academy of Medical Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Liao Ning, MD,PhD

Role: STUDY_DIRECTOR

Guangdong Academy of Medical Sciences

Locations

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Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GGHBCRG-IORT-WRT-DCIS

Identifier Type: -

Identifier Source: org_study_id

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