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

Invasive Lobular and Ductal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01295723
• Other study ID #: 11-003 Mobetron
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: St. Joseph Hospital of Orange
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ductal
• Invasive Lobular and Ductal Carcinoma

Intervention

Radiation:
• Hypofractionated Whole Breast Radiation Therapy
Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days postoperatively (week 2-8 post-op) Single reference dose per fraction: 2.7 Gy (ICRU) Number of fractions: 15 Number of fractions per week: 5 Regular Radiation Therapy breaks: Weekend/ Holidays (not exceeding 7 days break) Total dose: 50.5 Gy (40.5 WBRT + 10 Gy boost) Radiation: Intraoperative Electron Radiation Therapy
• Intraoperative Electron Radiation Therapy
Intraoperative Electron Radiation Therapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on mobile or fixed linac with variable electron energies in the range of 4-12 MeV

Locations

Country	Name	City	State
United States	St. Joseph Hospital of Orange	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph Hospital of Orange

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of acute and late toxicity	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	5 years
Secondary	Cosmetic Evaluation	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.	5 years
Secondary	Disease Free Survival	Recurrence assessments as documented at post-op follow-ups per protcol.	5 years
Secondary	Overall Survival	The length of time from the start of treatment to death within the 5 year period.	5 Years