Single Fraction Intraoperative Radiotherapy

Stage 0 Breast Carcinoma Clinical Trial

Official title:

Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688388
• Other study ID #: 12-001 Single Fraction IORT
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: February 2022

Study information

• Verified date: May 2022
• Source: St. Joseph Hospital of Orange
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2022
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 41 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma, Lobular
• Invasive Ductal and Invasive Lobular Breast Carcinoma
• Stage 0 Breast Carcinoma
• Stage I Breast Carcinoma
• Stage II Breast Carcinoma

Intervention

Procedure:
• Intraoperative Radiotherapy
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.

Locations

Country	Name	City	State
United States	St. Joseph Hospital of Orange	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph Hospital of Orange

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cosmetic Evaluation	Assessment of cosmetic outcome according to 5-point scoring system; Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60; At yearly follow-up (photodocumentation in standardized positions) for 5 years	5 years
Secondary	Recurrence Assessment	Recurrence is assessed at month 6, 12, 24, 36, 48, 60	5 years