Radiotherapy Side Effect
Conditions
Brief summary
A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.
Detailed description
This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).
Interventions
RADIATIONSequential boost
Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation
RADIATIONConcomitant boost
Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Histopathologically proven breast cancer resected by lumpectomy * Female patient * Invasive breast cancer * Negative surgical margin * Age \< or equal 50 years, or high-grade irrespective of age * Appropriate stage for protocol entry i.e. no metastasis * Performance Status 0-2 * Hormone receptor status: 1. ER/PR Known 2. Borderline results are considered positive
Exclusion criteria
* Metastatic patients * Paget's disease of nipple * Non-epithelial breast malignancy e.g. sarcoma, lymphoma * Unresected suspicious microcalcifications in the same or contralateral breast * Pregnant women * Inability to delineate lumpectomy cavity * Psychiatric or addictive disorders rendering treatment or follow-up difficult
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Breast Cosmetic Outcome | 1 year | Rate the qualities of the treated breast as compared with the untreated breast using European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction: Breast Questionnaire (Breast Q) | 1 year | Using Breast Questionnaire (Breast Q) |
| Acute Toxicity (Breast Skin) | During treatment and up to 3 months after treatment | Using Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria |
| Late Toxicity (Breast Skin, Heart, Lungs) | 1 year | Using Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria |
Countries
Egypt
Outcome results
None listed