Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Mona Salem
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Patient quality of life assessment.
- Last Updated
- 5 years ago
Overview
Brief Summary
The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.
Detailed Description
Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.
Investigators
Mona Salem
Assistant Lecturer of clinical oncology
Kasr El Aini Hospital
Eligibility Criteria
Inclusion Criteria
- •Histologically proven diagnosis of invasive breast adenocarcinoma.
- •Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
- •No macroscopic evidence of distant metastases at diagnosis.
Exclusion Criteria
- •Prior radiation to the thoracic region.
- •Patients with synchronous or prior malignancy.
- •Positive surgical margins.
Outcomes
Primary Outcomes
Patient quality of life assessment.
Time Frame: six months
according to FACT-B
Patient satisfaction.
Time Frame: six months
according to FACIT-TS-PS
Change in cosmetic breast appearance
Time Frame: six months
according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
Acute radiation toxicity assessment
Time Frame: six months
according to the RTOG acute toxicity scale: 0 No visible change, 1 faint/dull erythema, 2tender/ bright +- dry desquamation, 3 patchy moist desquamation, 4 conflueunt moist desquamation, pitting edema, 0 is the best and 4 is the worse.