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


Phase 1/Phase 2
41 Years
N/A
Open (Enrolling)
Female
Invasive Ductal and Invasive Lobular Breast Carcinoma, Stage 0 Breast Carcinoma, Stage I Breast Carcinoma, Stage II Breast Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity Assessment

Outcome Description:

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

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Lawrence Wagman, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

St. Joseph Hospital of Orange

Authority:

United States: Food and Drug Administration

Study ID:

12-001 Single Fraction IORT

NCT ID:

NCT01688388

Start Date:

February 2012

Completion Date:

February 2022

Related Keywords:

  • Invasive Ductal and Invasive Lobular Breast Carcinoma
  • Stage 0 Breast Carcinoma
  • Stage I Breast Carcinoma
  • Stage II Breast Carcinoma
  • Breast Cancer
  • Carcinoma
  • Radiotherapy
  • Intraoperative Radiotherapy
  • IORT
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Lobular

Name

Location
St. Joseph Hospital of Orange Orange, California  92868