Phase 2 Study of Adjuvant Radiotherapy in Breast Cancer Using a Once a Week Hypofractionated Regimen

November 15, 2017 updated by: Instituto do Cancer do Ceara

Weekly Hypofractionated Radiotherapy in Breast Cancer: a Phase 2 Clinical Trial

The implementation of a weekly hypofractionated radiation could be an advantageous alternative. The convenience of less treatment days could cause a greater adherence, decrease of costs and increase the offer of radiotherapy to major number of patients in underserved areas.

The purpose of this study is to determine in women with diagnosis of initial breast cancer undergoing breast-conserving surgery the effects of the adjuvant radiotherapy using a once a week regimen, with 5 fractions in total. The study will analyze the acute toxicity of radiation, the patient's self referred quality of life, the cosmetic breast appearance, as well the oncological safety. It will also be analyzed the viability of this more contracted regimen in our community setting, regarding the patient's adherence to the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients will be told about the study and have all their questions clarified. After agreeing to participate in the study they must sign a declaration of free and informed consent.

All the radiation treatments will be carried out in the Radiotherapy Department of the Haroldo Juacaba Hospital. The primary intention of the radiotherapy (RT) is to treat the entire breast. Initially, with the patient in supine position and the making of an individual immobilization device, it will be done a pre-planning in a conventional radiotherapy simulator. After that, a CT-scan will be performed for the three-dimensional conformal radiation planning.

The contouring of the treatments volumes (target volumes and organs-at-risk) and the dosimetric calculations will be performed in the Eclipse treatment planning system (Varian Medical Systems, Palo Alto-CA, USA). The total dose prescribed will be of 30 Gy, in 5 fractions of 6.0 Gy, 1 fraction per week, 1 week apart in the same weekday. In the dosimetric analysis, at least 95% of the breast target-volume must be covered by ≥ 95% of the prescription dose. The point of maximum dose must be less than 110%.

Clinical evaluations will be carried out weekly during the treatment course and in the 4th and 8th weeks after the conclusion of RT. The toxicity will be graduated according to the Common Toxicity Criteria for Adverse Events (CTCAE), v 3.0.

Breast photographs will be held initially and 6 and 12 months after treatment. Breast cosmetic appearance will evaluated by 2 radiation oncologists and classified according to the Harvard scale. The patient's self-referred quality-of-life (QoL) data will be collected in 3 different moments, before the begging of RT just at the end and 1 month after the conclusion of RT. The QoL evaluation tools to be used are the European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 and the breast cancer specific module QLQ-BR23 questionnaires. The projected sample size is 40 patients.

Which patient has the right of no longer be part of the study at any time, if this will be her desire. The study will be interrupted in the case of severe toxicity (≥ grade IV), death caused by the treatment and/or local recurrence superior than the expected, as the reported by literature. Interim analyzes will be performed every 6 months for better monitoring of these possible outcomes.

Study Type

Interventional

Enrollment (Actual)

44

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
    • CE
      • Fortaleza, CE, Brazil, 60430-230
        • Radiotherapy Department, Instituto do Cancer do Ceara

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Breast carcinoma
  • Submitted to breast conserving surgery with pos-op free margins status
  • Early stage: pT1-2N0

Exclusion Criteria:

  • Positive pathological margins
  • Submitted to chemotherapy, either neoadjuvant or adjuvant
  • Previous breast reconstruction
  • Bilateral breast cancer
  • Previous thoracic irradiation
  • Collagen disease

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Weekly radiation
once-weekly breast irradiation
Radiation: once-weekly breast irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number patients with adverse events
Time Frame: RT duration, 5 weeks
RT duration, 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cosmetic appearance
Time Frame: One year
One year
Number of local failures after RT
Time Frame: One year
One year
Cancer specific survival
Time Frame: One year
One year
Quality-of-life
Time Frame: one month
one month
Adherence to RT regimen
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

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

Sponsor

Instituto do Cancer do Ceara

Investigators

  • Principal Investigator: Conceicao Souza, MD, PhD, Instituto do Cancer do Ceara

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

November 1, 2013

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

October 13, 2013

First Submitted That Met QC Criteria

October 15, 2013

First Posted (ESTIMATE)

October 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009/2013

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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