This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa. Patients in both treatment arms will receive radiotherapy with a shortened fractionation schedule. Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the chest-wall and supraclavicular fossa in terms of loco-regional control, survival and treatment toxicity.
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.
RT 40 Gy in 15 fractions
RT 40Gy in 15 fractions
Instituto Naciolal de Oncologia y Radiobiologia (INOR)
Havana, Cuba
RECRUITINGCairo National Cancer Institute
Cairo, Fom El-Khalig, Egypt
RECRUITINGAlexandria Ayadi Almostakbal Oncology Cenre.
Local control.
The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.
Time frame: 4 years
Regional control.
The presence/absence of recurrent disease in the axilla, ipsilateral supraclavicular/infraclavicular nodes and or ipsilateral skin/soft tissue in the regional areas.
Time frame: 4 years
Overall survival.
Time frame: 4 years
Disease-free survival.
Time frame: 4 years
Acute adverse events.
During treatment and up to 90 days following the completion of treatment.
Time frame: 4 years
Late adverse events.
More than 90 days after the completion of radiation therapy.
Time frame: 4 years
Patients' demographics.
Time frame: 4 years
Reproductive history.
Number of pregnancies, miscarriages. Menstrual History.
Time frame: 1 year
Family history.
Family history of breast cancer.
Time frame: 1 year
Characterization of molecular profile of breast cancer patients.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Alexandria, Egypt
Korle Bu Teaching Hospital
Accra, Ghana
RECRUITINGInstitut National d'Oncologie
Rabat, Morocco
RECRUITINGUniversity of Ibadan College Hospital
Ibadan, Nigeria
RECRUITINGInstitut of Radiotherapy and Nuclear Medicine (IRNUM)
Peshawar, Pakistan
RECRUITINGInstituto Nacional de Enfermedades Neoplasicas
Lima, Peru
RECRUITINGCerraphasa Medical Faculty
Istanbul, Turkey (Türkiye)
RECRUITINGTime frame: 4 years