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

Liao Ning

Status: Active, not recruiting

Conditions: Breast Neoplasms

Treatments: Radiation: Intraoperative Radiotherapy; Radiation: Whole breast radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02389699

GGHBCRG-IORT-WRT-DCIS

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Intraoperative Radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: Intraoperative Radiotherapy

whole breast radiation

Active Comparator group

Description:

WRT:whole breast radiation after BCS with 46-50 Gy

Treatment:

Radiation: Whole breast radiation