Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Alexandria University
Updated on 19 February 2024
cancer
breast cancer
ct scan
x-rays
metastatic breast cancer
mastectomy
invasive breast cancer
immunomodulators
ct scan chest
stage iv breast cancer
immunostimulant
adjuvant radiotherapy
hypofractionated radiation therapy
adjuvant

Summary

Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years

Description

In Alexandria, the number of working linear machines are limited with overcrowded waiting list which lead to prolongation of overall treatment time and delay in starting radiotherapy. Providing the available data, Principle investigator is conducting this study in parallel with fast forward protocol to provide an alternative cost effective approach to patients.

The rationale behind hypofractionation depends mainly on the alpha beta ratio (/) 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

Details
Condition Breast Cancer, Breast Cancer
Age 50years - 100years
Treatment Hypofractionation, ultraHypofractionation
Clinical Study IdentifierNCT04434677
SponsorAlexandria University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 50 years old
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

Evidence of distant metastases
Prior irradiation
Inflammatory breast cancer
Tumor with T4 (skin nodules or fixed to chest wall or ulceration)
Tumor with positive margins
Clear my responses

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