Overview

This trial is active, not recruiting.

Condition breast neoplasms
Treatments intraoperative radiotherapy, whole breast radiation
Sponsor Liao Ning
Start date June 2014
End date June 2019
Trial size 74 participants
Trial identifier NCT02389699, GGHBCRG-IORT-WRT-DCIS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
intraoperative radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
(Active Comparator)
WRT:whole breast radiation after BCS with 46-50 Gy
whole breast radiation
whole breast radiation after BCS with 46-50 Gy

Primary Outcomes

Measure
ipsilateral breast tumor recurrence rate after surgery within five years
time frame: Within 5 years after surgery
Disease free survival after surgery within five years
time frame: Within 5 years after surgery

Secondary Outcomes

Measure
Overall survival after surgery within ten years
time frame: Within ten years after surgery

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Guangdong Academy of Medical Sciences.