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Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)


N/A
40 Years
N/A
Open (Enrolling)
Both
Invasive Lobular and Ductal Carcinoma

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Trial Information

Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)


Inclusion Criteria:



- Histological proven invasive breast carcinoma (ductal and lobular)

- Age > 40 years

- Karnofsky performance status >70%

- 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
4 cm (invasive foci)

- Nodal Status: NO-1

- Clear surgical margins: R0; min 2mm. Re-excision after IOERT is permitted but not
required to achieve (-) margin.

- All grades G1 - G3

- Any hormonal receptor and Her-2 status

- Informed consent

Exclusion Criteria:

- In-situ Carcinoma without invasive component or multifocal disease > 4 cm

- Tumor stage: T3 or 4

- Nodal Status > N1 pathologically

- Surgical margins < 2mm

- Multicentricity

- Previous radiotherapy to the involved breast

- Karnofsky Index < 70%

- Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis
obliterans, systemic lupus.

- Distant metastases

- Unable to provide written consent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of acute and late toxicity

Outcome Description:

Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - systems: At the end of Radiation Therapy At time of first follow-up investigation (week 8 - 10) 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

Afshin Forouzannia, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange

Authority:

United States: Institutional Review Board

Study ID:

11-003 Mobetron

NCT ID:

NCT01295723

Start Date:

January 2011

Completion Date:

December 2021

Related Keywords:

  • Invasive Lobular and Ductal Carcinoma
  • Breast cancer
  • Radiation therapy
  • Mobetron
  • IOERT
  • IORT
  • Hypofractionated radiation therapy
  • Partial breast radiation
  • Carcinoma
  • Carcinoma, Ductal, Breast
  • Carcinoma, Lobular
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal

Name

Location
St. Joseph Hospital of Orange Orange, California  92868