Intra-operative Radiotherapy For Breast Cancer Women After NSM

NCT ID: NCT02389686

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Despite the advancement and increasing use of nipple-sparing mastectomy (NSM) is still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). 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.INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Without Radiotherapy

Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intraoperative Radiotherapy

Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC).

Group Type EXPERIMENTAL

INTRABEAM (Carl Zeiss, Oberkochen, Germany)

Intervention Type DEVICE

Boost with 16 Gy during NSM for nipple-areola complex (NAC)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

INTRABEAM (Carl Zeiss, Oberkochen, Germany)

Boost with 16 Gy during NSM for nipple-areola complex (NAC)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Tumor diameter ≤3 cm
* Tumor from the papilla\>2cm
* Low grade ductal carcinoma in situ
* Candidate for breast-conserving surgery
* Must have undergone lumpectomy with negative margins or minimal margin involvement
* Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
* No evidence of metastatic disease
* Informed consent

Exclusion Criteria

* No informed consent
* Tumor size \> 3 cm
* Tumor from the papilla≤2cm
* Intermediate or high grade ductal carcinoma in situ
* Invasive carcinoma
* No indication for a boost
Minimum Eligible Age

17 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Liao Ning

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Liao Ning

MD,PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Liao Ning, MD,PhD

Role: STUDY_DIRECTOR

Guangdong Academy of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Liao Ning, MD,PhD

Role: CONTACT

+86 83827812

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wen LingZhu

Role: primary

13763316144

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GGHBCRG-IORT-NSM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.