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

Liao Ning

Status: Enrolling

Conditions: Breast Neoplasms

Treatments: Device: Intraoperative Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02389673

GGHBCRG-IORT-DCIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

222 participants in 2 patient groups

Without Radiotherapy

No Intervention group

Description:

Patients just accept breast-conversing surgery without radiotherapy.

Intraoperative Radiotherapy

Experimental group

Description:

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

Treatment:

Device: Intraoperative Radiotherapy