Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04580784
• Other study ID #: FAST feasibility in CU
• Status: Recruiting
• Phase: Phase 2
• Start date: December 10, 2018
• Est. completion date: May 2024

Study information

• Verified date: October 2020
• Source: Kasr El Aini Hospital
• Contact: Mona M Salem, MSc
• Phone: 00201007731412
• Email: mona.m.salem[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2024
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiotherapy Side Effect

Intervention

Radiation:
• Weekly 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

Locations

Country	Name	City	State
Egypt	Kasr El AiniH	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Mona Salem	Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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