Observational Study on Acute Skin Toxicity Associated With Hypofractionated Radiotherapy To Whole Breast Based On UK FAST FORWARD Protocol
Observational study on acute skin toxicity associated with breast radiotherapy treatment
General Information
Study Information
During COVID-19 coronavirus pandemic, we foresee the needs to keep patients hospital visits to the absolute minimal and reduce the resources straining therapy where possible to ease the workload of our healthcare workforce. According to international guidelines on radiation therapy for breast cancer during the COVID -19 pandemic, approach involving fewest patient visits and duration without compromising oncological outcome is recommended.
UK FAST FORWARD phase 3 study of hypofractionated schedules results confirm that 26 Gy in 5 fractions is as effective and safe as an international standard15 fractions regimen after primary surgery for early breast cancer. We carried out research among this group of patients to find out the acute / early toxicities associated with this new treatment approach.
Inclusion & Exclusion Criteria
4.1.1 Patients who had undergone either breast conservation surgery or mastectomy, pathological reported T1-3 lesion with complete resection, irrespective of estrogen/ progesterone and HER-2 receptor status , whether they have received neoadjuvant chemotherapy or not
4.1.2 Patient who underwent sentinel lymph node biopsy or axillary lymphadenectomy and reported with no nodes involvement
4.1.3 Patient who will receive radiotherapy to whole breast only , chest wall or whole breast plus tumour bed boost
4.1.4 A performance status score of 0-2 according to Eastern Cooperative Oncology Group (ECOG) criteria
Exclusion Criteria :
4.2.1. Patient with DCIS disease , ipsilateral microinvasive disease or non-gradeable tumour, previous breast cancer history
4.2.2 No concurrent chemotherapy allowed
4.2.3 Positive nodal disease at axillary, interpectoral and supraclavicular fossa
4.1.1 Patients who had undergone either breast conservation surgery or mastectomy, pathological reported T1-3 lesion with complete resection, irrespective of estrogen/ progesterone and HER-2 receptor status , whether they have received neoadjuvant chemotherapy or not
4.1.2 Patient who underwent sentinel lymph node biopsy or axillary lymphadenectomy and reported with no nodes involvement
4.1.3 Patient who will receive radiotherapy to whole breast only , chest wall or whole breast plus tumour bed boost
4.1.4 A performance status score of 0-2 according to Eastern Cooperative Oncology Group (ECOG) criteria
Exclusion Criteria :
4.2.1. Patient with DCIS disease , ipsilateral microinvasive disease or non-gradeable tumour, previous breast cancer history
4.2.2 No concurrent chemotherapy allowed
4.2.3 Positive nodal disease at axillary, interpectoral and supraclavicular fossa
Study Timeline
Gender :
1. To elicit the proportion of patient with any acute skin toxicity , defined as the worst grade reported from the start of radiotherapy till 6 weeks post radiotherapy
2. To elicit the proportion of patient with acute skin toxicity during radiotherapy, defined as the worst grade reported from the start to the end of radiotherapy
3. To elicit the proportion of patient with acute skin toxicity post radiotherapy, defined as the worst grade reported from at completion of radiotherapy until at least 6 weeks post radiotherapy
4. To report clinical toxicity and outcomes on review of 3month and 6month post radiotherapy
Sites
HOSPITAL KUALA LUMPUR
Team Members
HOSPITAL SULTAN ISMAIL
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