Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 breast-cancer
Started Dec 2018
Typical duration for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2018
CompletedFirst Submitted
Initial submission to the registry
June 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedOctober 8, 2020
October 1, 2020
1.9 years
June 7, 2019
October 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in cosmetic breast appearance
according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
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.
six months
Patient quality of life assessment.
according to FACT-B
six months
Patient satisfaction.
according to FACIT-TS-PS
six months
Study Arms (1)
Hypofractionation
EXPERIMENTALHypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior radiation to the thoracic region.
- Pregnancy.
- Patients with synchronous or prior malignancy.
- Positive surgical margins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mona Salemlead
- Kasr El Aini Hospitalcollaborator
Study Sites (1)
Kasr El AiniH
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mona Salem, MSc
Kasr El AiniH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Lecturer of clinical oncology
Study Record Dates
First Submitted
June 7, 2019
First Posted
October 8, 2020
Study Start
December 10, 2018
Primary Completion
November 1, 2020
Study Completion
May 1, 2024
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share