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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Invasive Lobular and Ductal Carcinoma	Radiation: Hypofractionated Whole Breast Radiation Therapy; Radiation: Intraoperative Electron Radiation Therapy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
Study Start Date :	January 2011
Estimated Primary Completion Date :	December 2013
Estimated Study Completion Date :	December 2021

Arms and Interventions

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Arm

Intervention/treatment

Experimental: 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.

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 Radiation: 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; Other Name: Mobetron

Outcome Measures

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Primary Outcome Measures :

1. Assessment of acute and late toxicity [ Time Frame: 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 :

1. Cosmetic Evaluation [ Time Frame: 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.
2. Disease Free Survival [ Time Frame: 5 years ]
3. Overall Survival [ Time Frame: 5 Years ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
St. Joseph Hospital of Orange	Recruiting
Orange, California, United States, 92868
Contact: Nancy Walter 714-734-6220
Contact: Gitana Davila 714-734-6220 ext 41477 Gitana.Davila@stjoe.org
Principal Investigator: Afshin Forouzannia, M.D.
Sub-Investigator: Robert Ash, M.D.
Sub-Investigator: Venita Williams, M.D.
Sub-Investigator: Jay Harness, M.D.
Sub-Investigator: Michele Carpenter, M.D.

Sponsors and Collaborators

St. Joseph Hospital of Orange

Investigators

Principal Investigator:	Afshin Forouzannia, M.D.	The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange

More Information

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Responsible Party:	St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier:	NCT01295723 History of Changes
Other Study ID Numbers:	11-003 Mobetron
First Posted:	February 14, 2011
Last Update Posted:	September 19, 2012
Last Verified:	September 2012

Keywords provided by St. Joseph Hospital of Orange:

Breast cancer; Radiation therapy; Mobetron; IOERT	IORT; Hypofractionated radiation therapy; Partial breast radiation

Additional relevant MeSH terms:

Carcinoma, Ductal; Carcinoma, Ductal, Breast; Carcinoma, Lobular; Carcinoma, Intraductal, Noninfiltrating; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type	Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Breast Carcinoma In Situ; Carcinoma in Situ