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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04580784
Other study ID # FAST feasibility in CU
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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