Intraoperative Radiotherapy for Korean Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02213991
• Other study ID #: K-IORT
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 5, 2014
• Last updated: February 13, 2018
• Start date: August 2014
• Est. completion date: March 2020

Study information

• Verified date: February 2018
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy for the replacement of boost-external beam radiotherapy in Korean women who are candidates for breast-conserving treatment.

Description:

Local toxicity checklist

• Hematoma needing surgical evacuation

• Seroma needing more than three aspirations

• Skin breakdown or delayed wound healing

• Any complication needing surgical intervention

• Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other.

• Any complication of RTOG toxicity grade more than 2

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 215
• Est. completion date: March 2020
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed and newly diagnosed non-metastatic operable primary breast cancer

• Primary tumor <5cm, measured by ultrasonography - N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)

• Age =18-years women with good performance status (ECOG 0-1)

• No breast operation is allowed except diagnostic biopsy

• Women with ductal carcinoma in situ diagnosed by preoperative biopsy are allowed

Exclusion Criteria:

• Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.

• Patients who received prior chemotherapy or radiotherapy for breast cancer

• Patients who have history of cancer other than in situ uterine cervix cancer or non-melanoma skin cancer

• The depth of tumor from skin measured by ultrasonography is less than 1cm.

• Contraindications to breast conservative surgery

• Multicentric breast cancer (tumors in more than one quadrant)

• Diffuse malignant appearing microcalcification

• Prior therapeutic radiation to the breast region

• Small breast, which is not possible to achieve clear margins in relation to a cosmetically acceptable result

• History of collagen vascular disease, such as active scleroderma and active lupus

• Postoperative exclusion

• Patients who require re-excision due to positive resection margin

• The depth of cavity from skin after lumpectomy is less than 0.5cm

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Intraoperative radiotherapy using Intrabeam®
Operation day Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. Purse string suture pulles up tissues and wraps up the applicator. Intraoperative radiotherapy using Intrabeam® (20Gy) is followed. After IORT, applicator was out of the operative field, and usual wound closure will be done. Postoperative period Chemotherapy WBRT (46 Gy) for 4~5 weeks Endocrine therapy or target therapy

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute local toxicity in breast receiving IORT	Acute local toxicities of ipsilateral breast occurred within 6 months after IORT; Local toxicity checklist; Hematoma needing surgical evacuation; Seroma needing more than three aspirations; Skin breakdown or delayed wound healing; Any complication needing surgical intervention; Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other.; Any complication of RTOG toxicity grade more than 2; Expected number of patients with acute local toxicites associated with IORT-booster treatement is 32.; Considering a drop-out rate of 10%, the trial would need to enroll 215 patients in total.	Up to 6 months
Secondary	Delayed local toxicity	Monitoring of local toxicity evaluated at 2 years and 5 years	Up to 5 years
Secondary	Cosmesis	Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0	Up to 2 years
Secondary	Local tumor recurrence in ipsillateral breast	IBTR rate at 5 years	Up to 5 years
Secondary	Dosimetray	-Dosimetry in tumor cavity and correlation with acute and late complication rates; Identification of anatomical indication; MRI volumetry (Breast-to-tumor ratio); Skin depth measured at preoperative US	At time of surgery