Breast Cancer Clinical Trial
Official title:
Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 2024 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: 1. Histologically proven diagnosis of invasive breast adenocarcinoma. 2. Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery). 3. No macroscopic evidence of distant metastases at diagnosis. Exclusion Criteria: 1. Prior radiation to the thoracic region. 2. Pregnancy. 3. Patients with synchronous or prior malignancy. 4. Positive surgical margins. |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr El AiniH | Cairo |
Lead Sponsor | Collaborator |
---|---|
Mona Salem | Kasr El Aini Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cosmetic breast appearance | according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor | six months | |
Primary | Acute radiation toxicity assessment | 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. | six months | |
Primary | Patient quality of life assessment. | according to FACT-B | six months | |
Primary | Patient satisfaction. | according to FACIT-TS-PS | six months |
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