Adjuvant Whole Breast Irradiation in Five Fractions Versus Fifteen Fractions in Early Breast Cancer

November 4, 2021 updated by: Heba Ali Elsagheer, Sohag University
the study aiming for compairing results of hypofractionaton radiotherapy treatment in patient with early breast cancer between two arms the first arm recieving five fractions and the other arm recieving fifteen fraction

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: mohamed s gaber, professor
  • Phone Number: 002 01025876769

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the study includes patients with early breast cancer recieving adjuvant radiotherapy in hypofractionation pattern the first arm recieving 15 fraction and the seconed arm recieving five fractions

Description

Inclusion Criteria:

  • age group ( 18-80) years
  • breast conservation surgery
  • Stages (pT1-3, pN0-1, M0) breast cancer.
  • Any histological type of invasive breast cancer.
  • All grades of breast cancer (I,II,III)

Exclusion Criteria:

  • Stage (III or IV) breast cancer.
  • Metastatic breast cancer (MBC)
  • Recurrent breast cancer.
  • Patients' co-morbidities that contraindicate radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1 standared hypofractonation
Radiation: radiation therapy
the patient first is simulated then delineation is done
group 2 fast forward group
Radiation: radiation therapy
the patient first is simulated then delineation is done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-disease free survival
Time Frame: 2 years
the time free from disease
2 years
2- overall survival
Time Frame: 2 years
the period time from treatment till death
2 years
3- toxicity from treatment
Time Frame: 2 years
side effects from treatment
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

October 24, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (ACTUAL)

November 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-21-10-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

adjuvant whole breast irradiation in five fractions versus fifteen fraction in early breast cancer

IPD Sharing Time Frame

2 years

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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