NCT00581529

Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy

Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy in Early Stage Breast Cancer After Breast-Conserving Surgery

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I- II feasibility study for delivering partial breast irradiation (PBI) in selected patients with early stage, lymph node negative, breast cancer after breast-conserving surgery using accelerated Intensity Modulated Radiotherapy (IMRT).

Detailed description

This is a non-randomized Phase I-II feasibility study of partial breast irradiation with accelerated IMRT technique. In this study, patients will be eligible if the estimated risk of breast cancer elsewhere in the breast (beyond the tumor bed) is low. The radiation treatment will be available to women who are older than 40 years, have a DCIS (Ductal carcinoma in situ) or T1, N0, M0, (AJCC classification, version 6.0), non-lobular infiltrating carcinoma treated with breast-conserving surgery. Patients will undergo a pre-treatment planning free breathing CT with 5mm cuts in the treatment position, on a breast board, with both arms extended above their head that will be used to plan the traditional two field (tangent) plan. An Active Breathing Control (ABC) device will be used to minimize target motion due to breathing during a second CT scan. The lumpectomy cavity will be identified and delineated, and margins of approximately 1.5 cm in three dimensions will be used to allow for subclinical tumor extension and daily set-up error. The organs at risk (heart, lungs, contralateral breast) will be contoured on both CT scans. An inverse planning system and optimization tools will be employed in order to achieve the best IMRT plan (to minimize the dose to the heart, lungs and contralateral breast), that will be compared to the two field plan. If the IMRT plan is shown to be the optimal one, in terms of doses to organs at risk, then the patient will be enrolled in the protocol and will proceed with the treatment. Treatment will start approximately two weeks after the planning CT is obtained. All patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	IMRT	Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Timeline

• Start date: 2004-11-01
• Primary completion: 2010-10-01
• Completion: 2014-08-01
• First posted: 2007-12-27
• Last updated: 2017-10-31
• Results posted: 2014-08-28

Locations

1 site across 1 country: United States