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

Breast Neoplasms Clinical Trial

Official title:

Comparison of the Efficacy of Intra-operative Radiation Therapy After Conserving Surgery With Post-operative Whole Breast Radiotherapy for Women With Ductal Carcinoma in Situ

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02389699
• Other study ID #: GGHBCRG-IORT-WRT-DCIS
• Status: Active, not recruiting
• Phase: N/A
• First received: March 10, 2015
• Last updated: March 10, 2015
• Start date: June 2014
• Est. completion date: June 2024

Study information

• Verified date: March 2015
• Source: Guangdong Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: June 2024
• 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

• 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

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

Radiation:
• Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
• Whole breast radiation
whole breast radiation after BCS 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
Primary	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