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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02389699

Enrollment

Registered

2015-03-17

Start date

2014-06-30

Completion date

2024-06-30

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Intermediate and high grade ductal carcinoma in situ （DCIS）

Brief 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.

Interventions

RADIATIONIntraoperative Radiotherapy

Boost with 20 Gy during BCS, EBRT with 46-50 Gy

RADIATIONWhole breast radiation

whole breast radiation after BCS with 46-50 Gy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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.

Secondary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026