Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

Phase 2

• Conditions: Breast Cancer; Radiotherapy Side Effect
• Interventions: Radiation: Weekly hypofractionation for early breast cancer

• Registration Number: NCT04580784
• Lead Sponsor: Mona Salem

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.

Study Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2019-06-07
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08
• Primary Completion: 2020-11
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionation	Weekly hypofractionation for early breast cancer	Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction.	six months	according to FACIT-TS-PS
Patient quality of life assessment.	six months	according to FACT-B
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.

Trial Locations

Locations (1)

Kasr El AiniH; 🇪🇬 Cairo, Egypt