Trial Comparing 3 Schedules of Hypofractionated Whole Breast Irradiation in Females With Early Stage Breast Cancer

September 14, 2020 updated by: National Cancer Institute, Egypt

Randomized Trial Comparing 3 Schedules of Hypofractionated Whole Breast Irradiation in Females With Early Stage Breast Cancer

The establishment of conservative breast surgery (CBS) and whole breast irradiation (WBI) as an alternative to mastectomy was a process that occurred over two to three decades. Based on the available evidence, hypofractionated WBI may be safely offered to most women with ductal carcinoma insitu (DCIS) or early-stage invasive breast cancer after CBS. This prospective randomized clinical trial aims to evaluate the outcomes of one-week and once weekly schedules of WBI against the investigator's standard hypofractionated WBI ( 40 Gy /15 fraction /3 weeks) in females with early stage breast cancer after CBS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Radiotherapy Timing If the patient is not receiving chemotherapy, WBI is to be initiated within 9 weeks following lumpectomy or re-excision of margins. For patients receiving chemotherapy, WBI is to begin no fewer than 2 weeks and no more than 8 weeks after the last cycle of chemotherapy.
  2. Randomization:

138 patients will be randomized using permuted blocks randomization to 3 equal comparable arms.

- Dose Prescriptions

Arm 1:

One week WBI: 27Gy/5 fractions /1 week. 5.4 Gy/fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI.

Arm 2:

Once weekly WBI: 28.5 Gy/ 5 fractions/ 5 weeks. 5.7 Gy/fraction ± boost to tumor bed 5.7 Gy/ 1 fraction, one week after the end of WBI. WBI is given on the same day each week.

Arm 3:

Hypofractionated WBI 40 Gy/ 15 fractions/ 3 weeks. 2.67 Gy/ fraction ± boost to tumor bed 10 Gy/ 4 fraction / 4 days after the end of WBI.

3-Tumor bed boost A tumor bed boost is recommended to high-risk patients [Age < 50 years, high grade] according to the National Comprehensive Cancer Network (NCCN) guidelines.

4-Radiotherapy simulation, Localization and Outlining:

  • The guidelines for contouring will conform to the policies set by the Radiation Therapy Oncology Group (RTOG) Breast cancer Atlas. www.rtog.org/CoreLab/ContouringAtlases/BreastCancerAtlas.aspx
  • Megavoltage ( MV) photon beams with energies ≥ 6 MV are required.
  • Radiotherapy Planning:

Computed tomography based conformal radiotherapy (CT-based 3D-CRT) planning with tissue inhomogeneity correction is required .

5- Systemic Therapy

  • Chemotherapy Adjuvant chemotherapy may be given at the discretion of the patient's medical oncologist. The use of chemotherapeutic agents during radiation therapy is not allowed. The use of neoadjuvant chemotherapy is not allowed.
  • Hormonal therapy Patients with ER-positive and/or PR-positive tumors should be treated with hormonal therapy for a minimum of 5 years. The use of hormonal therapy during radiation therapy is allowed.

  • Trastuzumab Trastuzumab is given to HER2 positive patients. The use of Trastuzumab during radiation therapy is allowed.

    6-Surgical Treatment:

  • All patients will undergo CBS, axillary staging and/or dissection with negative surgical margins (sm).

  • Negative surgical margin (Curigliano, 2017)

    • Invasive breast cancer: no ink on tumor
    • DCIS: 2mm
  • Surgical clips will be used to define the tumor bed borders
  • Breast reconstruction and cosmetic breast implants are not allowed 7-Follow-up.

Schedule of Follow up:

  • History and physical exam for all randomized patients will occur every 3 months in the first 2 years after the date of end of radiotherapy treatment
  • Monitor and refer for lymphedema management.
  • Mammography will be requested annually

Study Type

Interventional

Enrollment (Actual)

152

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, 12345
        • NCI. Cairo University

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Tis, pT1-2, pN0-1, M0 disease
  • Invasive carcinoma of the breast or ductal carcinoma insitu [DCIS]
  • CBS (reconstruction is not allowed)
  • Negative surgical margin
  • Axillary staging &/or dissection

Exclusion Criteria:

  • pT3-4, pN2-3 breast cancer
  • Inadequate axillary lymph node dissection
  • Neoadjuvant chemotherapy
  • Non-epithelial breast malignancies such as sarcoma or lymphoma
  • Synchronous bilateral invasive or non-invasive breast cancer
  • History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.)
  • Past history of malignancy except
  • Basal cell skin cancer
  • CIN cervix uteri
  • Cosmetic breast implants (Patients who have had implants removed are eligible.)
  • Prior breast or thoracic RT for any condition
  • Collagen vascular disease, specifically systemic lupus, or scleroderma
  • Pregnancy or lactation at the time of radiotherapy. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: One week Whole Breast Irradiation
WBI: 27 Gy/5 fractions/1 week. 5.4 Gy /fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI.
Other: Whole Breast Irradiation
Whole Breast Irradiation after CBS in females with DCIS and early stage breast cancer
EXPERIMENTAL: Once weekly Whole Breast Irradiation
WBI: 28.5 Gy/ 5 fractions/ 5 weeks. 5.7 Gy/fraction ± boost to tumor bed 5.7 Gy/ 1 fraction, one week after the end of WBI. WBI is given on the same day each week.
Other: Whole Breast Irradiation
Whole Breast Irradiation after CBS in females with DCIS and early stage breast cancer
ACTIVE_COMPARATOR: 3 weeks Whole Breast Irradiation
WBI: 40.05 Gy/ 15 fractions/ 3 weeks. 2.67 Gy/ fraction ± boost to tumor bed 10 Gy/ 4 fraction / 4 days after the end of WBI
Other: Whole Breast Irradiation
Whole Breast Irradiation after CBS in females with DCIS and early stage breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity
Time Frame: 3 months from the start of whole breast irradiation
The proportion of patients with grade ≥3 toxicity according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria.
3 months from the start of whole breast irradiation
Cosmetic outcome
Time Frame: Annually after the end of whole breast irradiation for 5 years
measured by The European Organisation for Research and Treatment of Cancer (EORTC) breast cosmetic rating system (observer rating)
Annually after the end of whole breast irradiation for 5 years
Ibsilateral locoregional tumor control
Time Frame: Annually after the end of whole breast irradiation for 5 years.
must be confirmed by cytological/ histological assessment
Annually after the end of whole breast irradiation for 5 years.
patient-reported outcome measures (PROMs)
Time Frame: Annually after the end of whole breast irradiation for 5 years.
measured by The European Organisation for Research and Treatment of Cancer, EORTC Quality of Life questionnaire for breast cancer patients ( EORTC QLQ-BR 23).
Annually after the end of whole breast irradiation for 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
late toxicity
Time Frame: Annually after the end of whole breast irradiation for 5 years.
Late toxicity according to The Radiation Therapy Oncology Group/ The European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring schema
Annually after the end of whole breast irradiation for 5 years.
Distant disease-free survival
Time Frame: 5 years from the initial diagnosis of breast cancer
Defined as the time from initial diagnosis of breast cancer to first diagnosis of distant disease, regardless of the occurrence of any intervening local or regional failure, contralateral breast cancer, or non-breast second primary cancer.
5 years from the initial diagnosis of breast cancer
Overall survival
Time Frame: 5 years from the initial diagnosis of breast cancer
Defined as the time from initial diagnosis of breast cancer to date of death or last follow up.
5 years from the initial diagnosis of breast cancer

Collaborators and Investigators

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

Sponsor

National Cancer Institute, Egypt

Investigators

  • Principal Investigator: Marwa M El Awadly, National Cancer Institute, Cairo University, 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)

November 1, 2017

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

February 18, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (ACTUAL)

November 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201617090.3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing plan includes study protocol, statistical analysis plan, informed consent form and clinical study report.

IPD Sharing Time Frame

January 2021

IPD Sharing Access Criteria

marwa.awadly@nci.cu.edu.eg

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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