NCT01295723

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: St. Joseph Hospital of Orange · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Invasive Lobular and Ductal Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-01-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2011-02-14
• Last updated: 2022-05-11

Locations

1 site across 1 country: United States