Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04580784

Enrollment

Registered

2020-10-08

Start date

2018-12-10

Completion date

2024-05-31

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Radiotherapy Side Effect

Keywords

Breast cancer, Radiotherapy, Hypofractionation

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.

Detailed description

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.

Interventions

RADIATIONWeekly 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in cosmetic breast appearance	six months	according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
Acute radiation toxicity assessment	six months	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.
Patient quality of life assessment.	six months	according to FACT-B
Patient satisfaction.	six months	according to FACIT-TS-PS

Countries

Egypt

Contacts

Primary ContactMona M Salem, MSc

mona.m.salem@kasralainy.edu.eg00201007731412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026