Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
NCT ID: NCT04434677
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-06-28
2021-06-28
Brief Summary
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Detailed Description
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The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than other tumors such as head and neck. The lower the ratio the higher the dose per fraction is needed to compensate slower proliferating tumors. Also, the overall treatment time could affect the local recurrence of breast cancer which is increased with long duration of treatment.
This study will include at least 100 patients with non metastatic histologically proved breast cancer who are indicated for adjuvant radiotherapy.
The patients will be randomized into two arms:
* Control arm: will include 50 patients who will receive standard 40.05 Gray (2.67 Gy/fx) over 15 fractions with or without boost over 3 weeks biologically effective dose (BED) for early and late effect equal 50.74.Gy10 and 75.69 Gy3 respectively.
* Experimental arm: will include 50 patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks with BED for early and late effect equal 39.52 Gy10 and 71.07 Gy3 respectively
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypofractionation
Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
Hypofractionation
3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
Ultrahypofractionation
Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
ultraHypofractionation
3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
Interventions
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Hypofractionation
3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
ultraHypofractionation
3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
Eligibility Criteria
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Inclusion Criteria
* Informed consent.
* Either breast conservative surgery or mastectomy.
* Invasive breast cancer with p T1-3, p N0-2.
* Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest and ultrasound or CT scan chest and abdomen).
Exclusion Criteria
* Prior irradiation.
* Inflammatory breast cancer.
* Tumor with T4 (skin nodules or fixed to chest wall or ulceration).
* Tumor with positive margins.
50 Years
FEMALE
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Principal Investigators
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Ashraf M El-Enbaby, Prof
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Locations
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ACOD
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0201263
Identifier Type: -
Identifier Source: org_study_id
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