Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients

October 23, 2022 updated by: Rawda Ahmed Abdul Hakim Balata, Zagazig University

Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule.

The aim is to evaluate toxicity and disease control after implementation of accelerated hypofractionated 1 week chest wall irradiation in breast cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Operational Design Patient Assessment Pre-radiotherapy assessment is done to provide a baseline for use in further follow-up and to rule out metastasis. This includes detailed history taking, full physical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.

Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.

Setup, simulation and target definition For setup, patients were positioned on a wingboard with both arms raised above the head and radiopaque markers along breast borders. Subsequently, the 5-mm slice-thick axial CT images were acquired from the lower mandible aspect to 5 cm below contralateral inframammary fold. The CT images will be automatically transferred to a planning workstation, where the CTV and relevant organs-at-risk (OARs) will be outlined. The planning of the tangential fields will be based on the target volume delineation for the dose-volume distribution analysis. The heart and ipsilateral lung were separately contoured as organs at risk, the heart was outlined to the pulmonary trunk superiorly, including pericardium and excluding major vessels. For setup verification purposes, weekly digitally reconstructed radiographs (DRRs) were performed.

Evaluation of Treatment Follow-up is done for assessment of toxicity and disease-free and overall survival.

During follow-up, patients are examined after completion of radiotherapy and at 3 and 6 months. Surveillance includes a full clinical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.

Acute skin toxicity was assessed at the completion of radiotherapy and after 3 months (RTOG 2015), late skin toxicity was scored from 6 months after radiation and referred to the time of last examination (LENT/Soma Tables 1995). The maximal detected toxicity was scored according to the Common Terminology Criteria for Adverse Events, version 3.0, using the RTOG/EORTC toxicity scale associated with radiation as reference (NCI 2013) (Cox et al, 1995).

Admininistrative Design

Approvals for performing this study are obtained from:

A) The recruited cases; B) The Institutional Review Board (IRB) RESULTS Collected data will be presented in tables and suitable graphs and analyzed using SSPS package. Mean and standard deviations will be estimated for quantitative data and median for non-normally distributed data. Actuarial or life tables analysis will be used for estimating survival and long-rank test for comparison of curves. P value is significant at 0.05 level.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Egypt
    • Sharqia
      • Zagazig, Sharqia, Egypt, 44511
        • Zagazig University Hospitals

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • histological diagnosis of breast adenocarcinoma
  • prior modified radical mastectomy
  • negative resection margins (3 mm)
  • pathological stage pT1-pT2, N0-2 (AJCC, 2017)
  • no macroscopic evidence of distant metastases at diagnosis
  • Age 18-80 years
  • Normal hematological and biochemical laboratory tests
  • Written informed consent was obtained from all patients

Exclusion Criteria:

  • locally advanced disease pT3-pT4, N3
  • positive surgical margins
  • prior thoracic radiation
  • synchronous second primary tumor
  • distant metastases
  • pregnancy
  • presence of a concomitant psychiatric disorder precluding an aware informed consent.
  • age >80 years

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
The first group 50 patient (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week,
Radiation: adjuvant radiotherapy
Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
Active Comparator: group 2
the second group 50 patient (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
Radiation: adjuvant radiotherapy
Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection of breast shrinkage
Time Frame: three months after radiotherapy
breast size measured before and after radiotharapy
three months after radiotherapy
detection of breast shrinkage
Time Frame: 6 months after radiotherapy
breast size measured before and after radiotharapy
6 months after radiotherapy
breast on the treated side is indurated
Time Frame: 3 months after radiotherapy
the induration detected by palpation with comparison with the normal side
3 months after radiotherapy
detection of irregularity of breast shape
Time Frame: 3 months after radiotherapy
change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy
3 months after radiotherapy
breast on the treated side is indurated
Time Frame: 6 months after radiotherapy
the induration detected by palpation with comparison with the normal side
6 months after radiotherapy
detection of irregularity of breast shape
Time Frame: 6 months after radiotherapy
change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy
6 months after radiotherapy

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Rawda Balata, dr, Zagazig 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)

January 1, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Radiotherapy in breast cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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