Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients
Condition: Breast Cancer Radiotherapy
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer
      patients will presumably produce comparable toxicity and disease control in comparison to 3
      weeks schedule.

      The aim is to evaluate toxicity and disease control after implementation of accelerated
      hypofractionated 1 week chest wall irradiation in breast cancer patients.
    

Detailed description: 
      Operational Design Patient Assessment Pre-radiotherapy assessment is done to provide a
      baseline for use in further follow-up and to rule out metastasis. This includes detailed
      history taking, full physical examination, hematological and biochemical laboratory
      evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for
      left cancer breast, bone scan if indicated.

      Treatment schedule and delivery The patients who met the inclusion criteria were randomly
      divided into two groups, each group of 50 patients. The first group (arm A) will receive a
      dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over
      one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall
      (2.67 Gy per fraction) over three weeks.

      Setup, simulation and target definition For setup, patients were positioned on a wingboard
      with both arms raised above the head and radiopaque markers along breast borders.
      Subsequently, the 5-mm slice-thick axial CT images were acquired from the lower mandible
      aspect to 5 cm below contralateral inframammary fold. The CT images will be automatically
      transferred to a planning workstation, where the CTV and relevant organs-at-risk (OARs) will
      be outlined. The planning of the tangential fields will be based on the target volume
      delineation for the dose-volume distribution analysis. The heart and ipsilateral lung were
      separately contoured as organs at risk, the heart was outlined to the pulmonary trunk
      superiorly, including pericardium and excluding major vessels. For setup verification
      purposes, weekly digitally reconstructed radiographs (DRRs) were performed.

      Evaluation of Treatment Follow-up is done for assessment of toxicity and disease-free and
      overall survival.

      During follow-up, patients are examined after completion of radiotherapy and at 3 and 6
      months. Surveillance includes a full clinical examination, hematological and biochemical
      laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound,
      ECHO for left cancer breast, bone scan if indicated.

      Acute skin toxicity was assessed at the completion of radiotherapy and after 3 months (RTOG
      2015), late skin toxicity was scored from 6 months after radiation and referred to the time
      of last examination (LENT/Soma Tables 1995). The maximal detected toxicity was scored
      according to the Common Terminology Criteria for Adverse Events, version 3.0, using the
      RTOG/EORTC toxicity scale associated with radiation as reference (NCI 2013) (Cox et al,
      1995).

      Admininistrative Design

      Approvals for performing this study are obtained from:

      A) The recruited cases; B) The Institutional Review Board (IRB) RESULTS Collected data will
      be presented in tables and suitable graphs and analyzed using SSPS package. Mean and standard
      deviations will be estimated for quantitative data and median for non-normally distributed
      data. Actuarial or life tables analysis will be used for estimating survival and long-rank
      test for comparison of curves. P value is significant at 0.05 level.
    

Intervention name(s): adjuvant radiotherapy
Intervention type(s): Radiation
Intervention description(s): Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
Masking: None (Open Label)
Primary purpose: Treatment