Malignant neoplasm of breast. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: In the adjuvant ultrahypofraction radiotherapy group, a prescribed dose of 5.2 Gy per session will be used in 5 consecutive daily doses over a week, for a total dos
Sponsors
Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of invasive breast carcinoma Pathological stage T1-T2 and N0 Without metastasis Breast conservation surgery Negative surgical margin Radiotherapy started within 1 month after the last day of adjuvant chemotherapy ECOG performance status from 0 to 1 Without previous history of radiotherapy to the chest Informed consent to participate in the study Performing axillary surgery or sentinel lymph node biopsy and confirming the absence of lymph node involvement Desire for long-term follow-up
Exclusion criteria
Exclusion criteria: History of concurrent malignancy or within the past 5 years Pregnancy or breastfeeding Uncontrolled diabetes Active infection Psychiatric illnesses Severe lung diseases Systemic steroid treatment within 6 months prior to study entry Severe heart disease within 6 months prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of radiation therapy. Timepoint: Every week during the treatment period, on the last day of treatment and one week after the last day of treatment, and weekly in the first month and then within 60 days and 90 days after the start of treatment. Method of measurement: Radiation therapy dosimetry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Kalantari Khandani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed