Back to results

Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

Primary Purpose

Breast Cancer, Radiotherapy Side Effect

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Weekly hypofractionation for early breast cancer

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Radiotherapy, Hypofractionation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Histologically proven diagnosis of invasive breast adenocarcinoma.
Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
No macroscopic evidence of distant metastases at diagnosis.

Exclusion Criteria:

Prior radiation to the thoracic region.
Pregnancy.
Patients with synchronous or prior malignancy.
Positive surgical margins.

Sites / Locations

Kasr El AiniHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionation

Arm Description

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

Outcomes

Primary Outcome Measures

Change in cosmetic breast appearance

according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor

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.

Patient quality of life assessment.

according to FACT-B

Patient satisfaction.

according to FACIT-TS-PS

Secondary Outcome Measures

Full Information

NCT ID

NCT04580784

First Posted

June 7, 2019

Last Updated

October 7, 2020

Sponsor

Mona Salem

Collaborators

Kasr El Aini Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04580784

Brief Title

Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Recruiting

Study Start Date

December 10, 2018 (Actual)

Primary Completion Date

November 2020 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mona Salem

Collaborators

Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Radiotherapy Side Effect

Keywords

Breast cancer, Radiotherapy, Hypofractionation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionation

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Weekly hypofractionation for early breast cancer

Intervention 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

Primary Outcome Measure Information:

Title

Change in cosmetic breast appearance

Description

according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor

Time Frame

six months

Title

Acute radiation toxicity assessment

Description

Time Frame

six months

Title

Patient quality of life assessment.

Description

according to FACT-B

Time Frame

six months

Title

Patient satisfaction.

Description

according to FACIT-TS-PS

Time Frame

six months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically proven diagnosis of invasive breast adenocarcinoma. Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery). No macroscopic evidence of distant metastases at diagnosis. Exclusion Criteria: Prior radiation to the thoracic region. Pregnancy. Patients with synchronous or prior malignancy. Positive surgical margins.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mona M Salem, MSc

Phone

00201007731412

mona.m.salem@kasralainy.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mona Salem, MSc

Organizational Affiliation

Kasr El AiniH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kasr El AiniH

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dean's office

Phone

002025729584

Dean@kasralainy.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

We'll reach out to this number within 24 hrs