A Phase 2 interventional study of Weekly hypofractionation for early breast cancer in Breast Cancer and Radiotherapy Side Effect, sponsored by Mona Salem. Status unknown at 1 site in Egypt. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Mona Salem · Phase 2, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Mona Salem as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions.
Radiation: Weekly hypofractionation for early breast cancer
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
Change in cosmetic breast appearance
according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
Time frame: six months
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.
Time frame: six months
Patient quality of life assessment.
according to FACT-B
Time frame: six months
Patient satisfaction.
according to FACIT-TS-PS
Time frame: six months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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