Clinical trial NCT01295723: Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
Official title: Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Invasive Lobular and Ductal Carcinoma
Keywords: Breast cancer
Radiation therapy
Mobetron
IOERT
IORT
Hypofractionated radiation therapy
Partial breast radiation
Lead sponsor: St. Joseph Hospital of Orange
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of acute and late toxicity
timeFrame: 5 years
Secondary outcomes:
measure: Cosmetic Evaluation
timeFrame: 5 years
measure: Disease Free Survival
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 Years
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
Study officials:
affiliation: The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange
name: Afshin Forouzannia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: