Intraoperative Radiotherapy for Korean Patients With Breast Cancer

NCT02213991 | Unknown Phase 2

• 1 other identifier: K-IORT
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast Conservative Surgery; Intraoperative Radiotherapy; Local Toxicity; Whole breast radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Delayed local toxicity

  Up to 5 years

• Cosmesis

  Up to 2 years

• Local tumor recurrence in ipsillateral breast

  Up to 5 years

• Dosimetray

  At time of surgery

Study Arms (1)

Intraoperative Radiotherapy

EXPERIMENTAL

Intervention: Intraoperative Radiotherapy \* Operation day * Breast conservative surgery + Intraoperative radiotherapy 20 Gy 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. IORT with 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

Device: Intraoperative radiotherapy using Intrabeam®

Interventions

Intraoperative radiotherapy using Intrabeam® DEVICE

Operation day 1. Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. 2. Purse string suture pulles up tissues and wraps up the applicator. 3. Intraoperative radiotherapy using Intrabeam® (20Gy) is followed. 4. 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

Intraoperative Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients who require re-excision due to positive resection margin
• The depth of cavity from skin after lumpectomy is less than 0.5cm

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, 135720, South Korea

Location

Related Publications (1)

• Ahn SG, Bae SJ, Lee HW, Yoon CI, Kim JW, Lee IJ, Jeong J. A phase II study investigating the acute toxicity of targeted intraoperative radiotherapy as tumor-bed boost plus whole breast irradiation after breast-conserving surgery in Korean patients. Breast Cancer Res Treat. 2019 Feb;174(1):157-163. doi: 10.1007/s10549-018-5038-x. Epub 2018 Nov 22.

  PMID: 30467660 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joon Jeong, M.D. Ph.D.

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 12, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2020
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

KR (1)