Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Intra-operative Radiotherapy After Breast-conversing Surgery in Treating Women With Ductal Carcinoma in Situ Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02389673
• Other study ID #: GGHBCRG-IORT-DCIS
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2015
• Last updated: March 10, 2015
• Start date: October 2014
• Est. completion date: June 2026

Study information

• Verified date: March 2015
• Source: Guangdong Academy of Medical Sciences
• Contact: Liao Ning, MD,PhD
• Phone: +86 83827812
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Whether the patients with low grade ductal carcinoma in situ breast cancer should accept radiationtherapy is uncertain.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 find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Description:

Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: June 2026
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Tumor diameter < 5 cm

• 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 > 5 cm

• Intermediate or high grade ductal carcinoma in situ

• Invasive carcinoma

• No indication for a boost

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Device:
• Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Locations

Country	Name	City	State
China	Guangdong Academy of Medical Sciences	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Liao Ning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Overall survival after surgery within ten years	After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.	Within ten years after surgery	Yes