Breast Carcinoma
Conditions
Brief summary
* Cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth. * Worldwide, Breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and gastric cancer. * More than half of all breast cancer cases in the world occur in developing countries. Egypt has a high mortality rate from breast cancer, with a rate of 21.3 per 100,000 cases. Breast cancer is diagnosed at an advanced stage in 60 to 70% of cases in Egypt. The median age at diagnosis in Egypt is 48.5 years, which seems to be a decade younger than in Europe and North America.
Interventions
RADIATIONHypofractionation Radiotherapy.
Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks.
RADIATIONUltra-hypofractionation radiotherapy
Patients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Female patients 45 years of age or older who have had Oncoplastic Breast Surgery (OBS) or total mastectomy with adequate axillary clearance and a negative margin. * Breast carcinomas that is invasive (TXN1-3M0, T0N2-3 M0, T1N2-3M0, T2N2-3M0, T3N0-3M0, T4N0-3M0) whatever type of tumors biology. * All patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy
Exclusion criteria
* Metastatic breast cancer at the time of diagnosis proved clinically or radiologically. * Postoperative positive margin. * Carcinomas in situ. * Mesenchymal breast lesions. * Locoregional recurrent breast cancer. * Synchronous bilateral breast cancer. * very early breast cancer (T1-2N0M0,T1N1M0).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | 3 months | Rate of acute grade 2 toxicity or higher from the treatment till 3 months (NCI\_CTCAE). Each patient will be assesed weekly during radiotherapy and monthly for 3 months post radiotherapy. |
| Chronic toxicity | 6 months post treatment up to 2 years | Rate of chronic toxicity grade 2 or higher ( NCI\_CTCAE) from 6 months after radiotherapy up to 2 years. Each patient will be assessed before treatment and at 6,12 and 24 months from treatment. |
| Local recurrence | Up to 2 years | Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy. |
| Patient compliance | From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm | Compliance to treatment (number of interrupted days of radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From time of diagnosis up to 2 years post radiotherapy | Overall survival (Number of the surviving patients for 2 years in each arm of the study) |
Countries
Egypt
Contacts
Primary ContactNahla M Elmahdy, assistant lecturer
Backup ContactMohamed S gaber, professor
Outcome results
None listed