Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

Mona Salem

Status and phase: Unknown; Phase 2

Conditions: Radiotherapy Side Effect; Breast Cancer

Treatments: Radiation: Weekly hypofractionation for early breast cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT04580784

FAST feasibility in CU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hypofractionation

Experimental group

Description:

Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions.

Treatment:

Radiation: Weekly hypofractionation for early breast cancer