Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Fibrosis

There is no specific study intervention being used. Samples will be collected from participants undergoing standard of care radiotherapy at pre-specified timepoints.

Breast Cancer Radiotherapy

Zsolt Gabos, MD

To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma.

To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma. Autotaxin and LPA cause fibrosis in other situation, but they have not been tested in radiation-induced fibrosis. We will determine if the duration and magnitude of the autotaxin and LPA responses are prognostic for the 15-28% of patients who will develop fibrosis. This fibrosis will be detected by ultrasound and a novel application of elastography, which should provide much earlier and quantifiable fibrotic changes compared to conventional physical examination.

Prognostic Indicators for Radiation-induced Breast Fibrosis

Identifying Prognostic Indicators for the Development of Radiation-induced Breast Fibrosis

Measurement of longitudinal changes in plasma ATX in the irradiated breast.

Measurement of longitudinal changes in plasma LPA in the irradiated breast.

Measurement of longitudinal changes in plasma cytokines in the irradiated breast.

Measurement of longitudinal changes in plasma chemokines in the irradiated breast.

The ultrasound procedure will provide a 3D analysis of the breast structure as well as a measurement of breast elasticity. Fibrotic changes in the breast will be measured by combining the 3D analysis and breast elasticity indices (median (kPa), IQR (kPA) and IQR/median (%))

Radiotherapy associated toxicities will be assessed per CTCAE v5.0 by the study investigators.

AHS Cancer Control Alberta

Breast Diseases

Skin Diseases

The first group 50 patient (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,

the second group 50 patient (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.

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.

adjuvant radiotherapy

Rawda Balata, dr

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.

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.

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.

Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients

breast size measured before and after radiotharapy

the induration detected by palpation with comparison with the normal side

change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prognostic Indicators for Radiation-induced Breast Fibrosis	NCT05031065	Breast Cancer	Breast Cancer R...	18 Years -	AHS Cancer Control Alberta
Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients	NCT05591456	Breast Cancer R...	adjuvant radiot...	18 Years - 80 Years	Zagazig University

Spots Global Cancer Trial Database for breast cancer radiotherapy