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

Not Applicable

• Conditions: Invasive Lobular and Ductal Carcinoma
• Interventions: Radiation: Hypofractionated Whole Breast Radiation Therapy; Radiation: Intraoperative Electron Radiation Therapy

• Registration Number: NCT01295723
• Lead Sponsor: St. Joseph Hospital of Orange

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Primary Completion: 2021-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative Electron Radiation Therapy	Intraoperative Electron Radiation Therapy	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.
Intraoperative Electron Radiation Therapy	Hypofractionated Whole Breast Radiation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Assessment of acute and late toxicity	5 years	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

Secondary Outcome Measures

Name	Time	Method
Cosmetic Evaluation	5 years	Assessment of cosmetic outcome according to 5-point scoring system; * Before Whole Breast Radiation Therapy; * Not earlier than 7 months after Whole Breast Radiation Therapy; * At yearly follow-up (photodocumentation in standardized positions) for 5 years.
Overall Survival	5 Years	The length of time from the start of treatment to death within the 5 year period.
Disease Free Survival	5 years	Recurrence assessments as documented at post-op follow-ups per protcol.

Trial Locations

Locations (1)

St. Joseph Hospital of Orange; 🇺🇸 Orange, California, United States