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Completed

NCT Number: NCT01688388

Single Fraction Intraoperative Radiotherapy

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.

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Key information

Conditions

Invasive Ductal and Invasive Lobular Breast Carcinoma Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Lobular Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Stage 0 Breast Carcinoma Stage I Breast Carcinoma Stage II Breast Carcinoma

Age range

41 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph Hospital of Orange

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: IORT

Primary outcomes

  1. Toxicity Assessment

    Time frame: 5 years

    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

Secondary outcomes

  1. Cosmetic Evaluation

    Time frame: 5 years

    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

  2. Recurrence Assessment

    Time frame: 5 years

    Recurrence is assessed at month 6, 12, 24, 36, 48, 60

Sponsors and collaborators

Lead sponsor

St. Joseph Hospital of Orange

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2022
First posted
Sep 19, 2012
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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