Intra-operative Radiotherapy For Breast Cancer Women After NSM

• Sponsor: Liao Ning (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02389686
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 120
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy
• Study Start Date: Oct 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2019
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Without Radiotherapy Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.
Experimental: 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).	Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany); Boost with 16 Gy during NSM for nipple-areola complex (NAC)

Outcome Measures

Primary Outcome Measures

1. Ipsilateral breast tumor recurrence rate after surgery within five years [Within 5 years after surgery]

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

Secondary Outcome Measures

1. Disease free survival after surgery within five years [Within 5 years after surgery]

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

2. Overall survival after surgery within ten years [Within ten years after surgery]

   After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Academy of Medical Sciences	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Liao Ning

Investigators

• Study Director: Liao Ning, MD,PhD, Guangdong Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liao Ning, MD,PhD, Guangdong Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT02389686
• Other Study ID Numbers: GGHBCRG-IORT-NSM
• First Posted: Mar 17, 2015
• Last Update Posted: Mar 17, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Liao Ning, MD,PhD, Guangdong Academy of Medical Sciences: Ductal carcinoma in situ （DCIS）; Nipple-sparing mastectomy (NSM); Intraoperative radiotherapy (IORT); INTRABEAM
• Additional relevant MeSH terms: Breast Neoplasms; Carcinoma in Situ

Study Results

No Results Posted as of Mar 17, 2015