Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS

September 9, 2020 updated by: Rimoun Ramsis Anis Boutrus, National Cancer Institute, Egypt

Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery

A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).

Study Type

Interventional

Enrollment (Anticipated)

185

Phase

  • Not Applicable

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
      • Cairo, Egypt, 11796
        • National Cancer Institute, Egypt

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histopathologically proven breast cancer resected by lumpectomy
  • Female patient
  • Invasive breast cancer
  • Negative surgical margin
  • Age < or equal 50 years, or high-grade irrespective of age
  • Appropriate stage for protocol entry i.e. no metastasis
  • Performance Status 0-2

  • Hormone receptor status:

    1. ER/PR Known
    2. Borderline results are considered positive

Exclusion Criteria:

  • Metastatic patients
  • Paget's disease of nipple
  • Non-epithelial breast malignancy e.g. sarcoma, lymphoma
  • Unresected suspicious microcalcifications in the same or contralateral breast
  • Pregnant women
  • Inability to delineate lumpectomy cavity
  • Psychiatric or addictive disorders rendering treatment or follow-up difficult

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequential boost
Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus sequential boost 10 Gy/4 fx (2.5 Gy/fx) to lumpectomy cavity
Radiation: Sequential boost
Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation
Experimental: Concomitant boost
Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus concomitant boost 8 Gy/15 fx (0.53 Gy/fx) to lumpectomy cavity
Radiation: Concomitant boost
Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Breast Cosmetic Outcome
Time Frame: 1 year
Rate the qualities of the treated breast as compared with the untreated breast using European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction: Breast Questionnaire (Breast Q)
Time Frame: 1 year
Using Breast Questionnaire (Breast Q)
1 year
Acute Toxicity (Breast Skin)
Time Frame: During treatment and up to 3 months after treatment
Using Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
During treatment and up to 3 months after treatment
Late Toxicity (Breast Skin, Heart, Lungs)
Time Frame: 1 year
Using Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria
1 year

Collaborators and Investigators

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

Sponsor

National Cancer Institute, Egypt

Investigators

  • Study Director: Medhat El Sebaie, MD, National Cancer Institute, Egypt

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, 2018

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

July 7, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 201617079.3

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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