Resource-sparing Radiotherapy for Breast Cancer
Post-mastectomy radiotherapy (PMRT) substantially reduces the risk of loco- regional failure
as shown in several studies and meta-analyses. Two large trials for pre-menopausal
node-positive breast cancer patients treated with mastectomy and chemotherapy showed that
PMRT not only reduced loco- regional failure rates but also improved disease-free and
overall survival rates.
Although the benefit of PMRT is clear, the optimal volume of tissues to be covered by the
radiotherapy fields is controversial. Since the chest wall is the most likely location of
recurrence, there is uniform consensus that the chest wall should be irradiated. However,
areas of controversy exist regarding irradiation of the regional lymph nodes (axillary,
supraclavicular and internal mammary lymph nodes), optimal radiation dose, and
dose-fractionation.
If equivalent results could be achieved by omitting irradiation of the supraclavicular
region in patients receiving adjuvant systemic therapy, this will simplify and expedite
treatment in this patient population. Furthermore, the use of a shortened fractionation
schedule of 40 Gy in 15 fractions (2.67 Gy per fraction) over 3 weeks which has been used in
the UK and Canada for post-mastectomy patients for several decades will shorten the duration
of treatment by reducing the number of patient visits for radiotherapy and increase the
number of patients who can be treated. Treatment will be more convenient for patients and a
reduction in the number of treatments could result in savings for strained health care
systems.
This is a randomized comparison of two different radiotherapy field set-ups for
post-mastectomy treatment of locally advanced breast cancer. Patients who have undergone
modified radical mastectomy including axillary lymph node dissection will be randomized to
receive one of two radiotherapy treatment arms, A and B following the completion of adjuvant
chemotherapy. The radiotherapy for treatment Arm A consists of irradiation of the chest
wall only while Treatment Arm B includes irradiation of the chest wall and the ipsilateral
supraclavicular field. Patients on both treatment arms will receive radiation with a
shortened fractionation schedule. Patients will be evaluated for local control, regional
control, survival and treatment toxicity.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Local control.
The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.
4 years
No
Eduardo Rosenblatt, MD
Study Chair
International Atomic Energy Agency
United Nations: International Atomic Energy Agency
E3.30.25
NCT01452672
March 2007
December 2012
Name | Location |
---|