Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost
During the past ten years the Breast Cancer Radiotherapy Research team at NYU has conducted
a series of consecutive studies to optimize the safe delivery of accelerated radiotherapy to
partial and whole breast in the prone position, as summarized in a recent review of this
experience. The current protocol focuses on whole breast radiotherapy for women with stage
0-2 breast cancer treated by segmental mastectomy: it aims at further refining the role of
prone IMRT versus a 3D-conformal radiotherapy technique in this common subset of patients.
This study is an open label randomized trial. Patients will be randomized within cohort
defined by assigned treatment (3D CRT if IMRT not covered or IMRT) and within these primary
strata by menopausal status (pre/post) and by chemotherapy prior to radiation (yes/no). The
on-site treatment randomization assignments will done on site and treatment assignments will
be provided to the Research Nurse after she has confirmed eligibility. Patients will be
randomized within the primary strata based on presumed insurance coverage on consent to the
study to allow simulation to proceed. Should the coverage change, then the patient will be
re-randomized in the correct stratum and the initial randomization number will be retired
with a notation that the initial stratification was revised and patient re-randomized.
Patients will have completed all breast surgical procedures prior to accrual into this
protocol in order to establish eligibility criteria. Final pathology margins must be at
least 1 mm in all directions to be eligible. The patient may undergo re-excision if the
initial margins are involved or close (< 1mm). If the patient meets the eligibility criteria
after re-excision, she may be entered onto the study.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with acute radiation toxicity of Grade 2 or higher.
By accruing 1000 patients randomized in strata defined by the two approaches to either weekly or daily boost, we will be able to establish the feasibility using different techniques and toxicity of prone breast radiotherapy with a weekly versus a daily boost, with IMRT and with 3DCRT non-IMRT approaches.
Up to 90 days of radiation treatment
Silvia C. Formenti, M.D.
NYU Cancer Institute Department Radiation Oncology
United States: Institutional Review Board
|NYU Cancer Institute||New York, New York 10016|