Breast Cancer
Conditions
Brief summary
To compare the efficacy and safety of two hypofractionated adjuvant radiotherapy regimens 34 Gy in 10 fractions versus 40.05 Gy in 15 fractions in patients with breast cancer treated at the South Egypt Cancer Institute.
Detailed description
Female breast cancer (BC) has been the leading cause of cancer morbidity and mortality among women in the majority of countries for decades. In 2020, there were an estimated 2.3 million new cases and 685,000 deaths from female BC worldwide, which accounted for one in four cancer cases and one in six cancer deaths among women. u For women with newly diagnosed, non-metastatic breast cancer, treatment consists of a multidisciplinary approach that involves input from surgery, radiation oncology, and medical oncology. The objective of adjuvant radiation therapy (RT) is to eradicate any tumor deposits remaining following surgery for patients treated by either breast-conserving surgery or mastectomy . Doing so reduces risk of locoregional recurrence and improves breast cancer-specific and overall survivals. u A historical regimen of 25-28 fractions over 6 weeks was adopted for radiotherapy (RT) following breast- conserving surgery (BCS) and total mastectomy. An early assumption that breast cancer cell lines might be more sensitive to fractional doses than acute skin reactions and other squamous carcinomas lead to development of the hypofractionated RT (HypoRT) approach, which elevated fractional dose up to 3 Gy with reduced total dose/fractions, for obtaining radiobiological equivalence to a traditional regimen of 50-50.4 Gy in 25-28 fractions. u Recently, the American Society of Radiation Oncology released a task force guideline recommending hypofractionated radiotherapy for all women of any age whether they had received chemotherapy or not ,Their evidence-based recommendations were supported by studies from Canada and the United Kingdom. u Benefits of HypoRT include both, radiobiologic advantages and reduced length of treatment courses, for improving healthcare resources and patient convenience. Consequently, HypoRT has been widely adopted worldwide based on a series of randomized clinical trials . u Recently, HypoRT over 3 weeks and with shorter courses of 5 fractions have been recommended in treatment guidelines. u Regarding clinical outcomes of a 2-week fractionation schedule , it was observed that acute and late effects were acceptable with control rates similar to those reported in other trials with hypofractionation,Based on these findings we started a trial to compare a 3-week radiotherapy schedule with a 2-week schedule .
Interventions
DEVICEradiotherapy
Hypofractionated Adjuvant Radiotherapy in 2 versus 3 Weeks of Breast Cancer and effect skin toxicity and over all survival
Sponsors
Salwa Shawky Bakeet Ali
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged ≥18 years. Female or male patients with invasive carcinoma of the breast. Complete microscopic excision of primary tumor. Undergoing breast-conserving surgery (BCS) or modified radical mastectomy (MRM). ≥ Axillary lymph nodes dissected. T1\_4pN0\_3M0 disease. Neoadjuvant or adjuvant CTH . Signed informed consent and able to comply with follow up.
Exclusion criteria
* Evidence of distant metastases. Past history of malignancy. Prior radiotherapy to the chest region Simultaneous malignancy (except non-melanoma skin cancer or in situ cervical carcinoma) Connective tissue diseases (e.g., lupus erythematosus, scleroderma) Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival analyzed from the date of diagnosis. | through study completion, an average of 1 year | local control was defined as absence of disease in the irradiated areas.recurrence were categorized as local(breast or surgical bed), regional(lymphatic drainage of axillary, supraclavicular fossa or internal mammary chain),or distant (metastasis),and any associayion of these |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Acute Skin Toxicity | From start of radiotherapy through 3 months after completion of radiotherapy | Acute toxicities will be assessed according to RTOG criteria. The most severe toxicity presented will be reported. |
| Assessment of Late Skin Toxicity | From 3 months after completion of radiotherapy through study completion, an average of 1 year | Late toxicities will be assessed according to RTOG criteria. The most severe toxicity presented will be reported. |
Countries
Egypt
Contacts
Primary ContactSALWA SHAWKY BAKEET
Backup Contactsamir shehata mohamed, professor
Outcome results
None listed