Single Fraction Intraoperative Radiotherapy

NCT01688388 | Completed

• 1 other identifier: 12-001 Single Fraction IORT
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

Conditions

Invasive Ductal and Invasive Lobular Breast Carcinoma; Stage 0 Breast Carcinoma; Stage I Breast Carcinoma; Stage II Breast Carcinoma

Keywords

Breast Cancer; Carcinoma; Radiotherapy; Intraoperative Radiotherapy; IORT

Outcome Measures

Primary Outcomes (1)

• Toxicity Assessment

  Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system: * End of initial surgical phase: Week 1, 4 * First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months

  5 years

Secondary Outcomes (2)

• Cosmetic Evaluation

  5 years

• Recurrence Assessment

  5 years

Study Arms (1)

IORT Arm

EXPERIMENTAL

Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.

Procedure: Intraoperative Radiotherapy

Interventions

Intraoperative Radiotherapy PROCEDURE

Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.

Also known as: IORT

IORT Arm

Eligibility Criteria

• Age: 41 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ
• Age \> 40 years
• Karnofsky performance status \> 70%
• Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm
• Nodal Status: preoperatively N0
• Clear surgical margins: R0
• All grades G1 - G3
• Any hormonal receptor and HER-2 status
• Informed consent

You may not qualify if:

• Gender: male
• Tumor size: more than 2.5 cm
• Nodal status greater than or equal to N1 pathologically
• Multicentricity
• Previous radiotherapy to the involved breast
• Karnofsky Index \< 70%
• Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
• Distant metastases
• Pregnancy in woman of child bearing age
• Unable to provide written consent

Sponsors & Collaborators

• St. Joseph Hospital of Orange: lead

Study Sites (1)

St. Joseph Hospital of Orange

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Carcinoma, Lobular; Breast Carcinoma In Situ; Breast Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ

Study Officials

• Lawrence Wagman, M.D.

  St. Joseph Hospital of Orange

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 19, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

US (1)