Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer

April 2, 2024 updated by: Prevent Senior Institute

Phase II Study to Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for the Treatment of Early and Locally Advanced Breast Cancer

Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

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

  • Brazil
      • São Paulo, Brazil
        • Instituto de Pesquisa Prevent Senior

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patient;
  2. Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
  3. Age greater than or equal to 65 years;
  4. Breast-conserving surgery or mastectomy with or without axillary approach
  5. With or without neoadjuvant or adjuvant systemic treatment

Exclusion Criteria:

  1. Patients with previous thoracic irradiation;
  2. Patients with indication for bilateral thoracic irradiation;
  3. Patients with breast reconstruction with prosthesis or autologous tissue;
  4. Patients with compromised surgical margins after resection;
  5. pT1-pT2 pN0 patients undergoing radical mastectomy.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm Ultra-hypofractionated
5 fractions of 5.7 Gy every other day in the breast or chest wall region, with or without the inclusion of regional lymph node drainage chains
Radiation: adjuvant ultra-hypofractionated radiotherapy
adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity
Time Frame: Events of radiotherapy up to 3 months
Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0
Events of radiotherapy up to 3 months
Late toxicity
Time Frame: Events after 3 months of radiotherapy completion
Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification.
Events after 3 months of radiotherapy completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional free survival
Time Frame: 3 years
from the date of initiation of treatment until the date of recurrence or progression of locoregional disease evidence
3 years
Distant free survival
Time Frame: 3 years
from the date of initiation of treatment until the date of progression of distant disease evidence
3 years
Overall survival
Time Frame: 3 years
defined from the date of initiation of treatment until the patient's death
3 years
Cosmesis change
Time Frame: week 10 and week 26 after the end of the treatment

was assessed using the Harvard/NSABP/RTOG scale. The Harvard/NSABP/RTOG scale score is a 4-point breast cosmetic scale, which was assessed by clinicians at baseline (after surgery) and two additional times during follow-up.

  1. Excellent: When compared to the untreated breast, there is no difference or minimal difference in the size or shape of the treated breast. The breast texture is the same or slightly different. There may be thickening, scar tissue, or fluid buildup in the breast, but not enough to change the appearance.
  2. Good: There is a slight difference in the size or shape of the treated breast compared to the untreated breast or compared to the original appearance of the treated breast. There may be a slight reddening or darkening of the breast. Thickening or scar tissue inside the breast causes only a slight change in shape or size.
  3. Fair: Obvious difference in the size and shape of the treated breast. This change involves a quarter or less of the breast. There may be
week 10 and week 26 after the end of the treatment
QOL (Quality of Life) changes
Time Frame: 3 years

was assessed using the scales proposed by the EORTC (European Organization for Research and Treatment of Cancer). The EORTC QOQ-C30 and EORTC QLQ-BR-23 scales.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast volume and toxicity relationship
Time Frame: 3 years
We analyzed the impact of CTV (Clinical Target Volume) volume (representing breast size), and dosimetric data, with a special focus on the maximum dose and dose in homogeneity (defined as the absolute volumes of breast tissue exposed to ≥100%, ≥104% and ≥107% of the prescribed dose
3 years

Collaborators and Investigators

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

Sponsor

Prevent Senior Institute

Investigators

  • Principal Investigator: Marcel MF Fang, MD, Instituto de Pesquisa Prevent Senior

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 30, 2019

Primary Completion (Actual)

February 11, 2021

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 30, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSTITUTO PREVENT SENIOR - IPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

product manufactured in and exported from the U.S.

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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