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

Providence

Status: Unknown

Conditions: Invasive Lobular and Ductal Carcinoma

Treatments: Radiation: Intraoperative Electron Radiation Therapy; Radiation: Hypofractionated Whole Breast Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01295723

11-003 Mobetron

Details and patient eligibility

About

Hypofractionated intraoperative boost (HIOB) is defined as hypofractionated WBRT (40.5 Gy in 2.7 Gy per fraction) preceded by an intraoperative boost to the tumor bed (10 Gy IOERT). The HIOB study concept will test whether such a combined schedule is superior or iso-effective standard RT in terms of local control and cosmetic outcome.

Full description

The purpose of this research study is to find out the effects (good and bad) of adding a dose of radiation to the area of the cancer during surgery to whole breast radiation therapy (WBRT) after surgery. IOERT is the application of electron radiation directly to the residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used to treat patients who have cancer in the breast covering the entire breast tissue. Both immediate and long-term effects will be measured.

For patients with certain types of breast cancer, one standard treatment is removal of the area of cancer 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 of WBRT followed by 5-8 daily radiation treatments at the site where the lump was removed called a "boost". During this study, the single dose of electron irradiation (IOERT) given at the surgical site during the operation will replace the usual 5-8 days of localized radiation and the whole breast radiation will last 3 weeks.

Enrollment: 200 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Intraoperative Electron Radiation Therapy

Experimental group

Description:

A single dose of electron irradiation given at the surgical site during the operation to remove the cancerous tumor will replace the usual 5-8 days of localized radiation. Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days post operatively.

Treatment:

Radiation: Intraoperative Electron Radiation Therapy

Radiation: Hypofractionated Whole Breast Radiation Therapy