NCT05776147

Brief Summary

The radiotherapy scheme with extreme hypofractionation has gained space in clinical practice and, therefore, it is necessary to analyze the Brazilian national experience in selected patients with breast cancer, with the aim of evaluating the oncological outcomes and toxicities with the use of this treatment protocol.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

March 8, 2023

Last Update Submit

March 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Locoregional recurrence

    To evaluate the effectiveness of the extreme hypofractionation scheme, in 5 fractions of 5.2 Gy, in women with breast cancer

    18 months

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with breast cancer undergoing radiotherapy with extreme hypofractionation.

You may qualify if:

  • Women over 18 years old;
  • Diagnosis of breast cancer of any molecular subtype;
  • Undergoing extreme hypofractionated radiotherapy (5 x 5.2Gy) postoperatively;
  • Treated from December/2019 onward;
  • With clinical and treatment data available in medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

ICC - Instituto do Câncer do Ceará

Fortaleza, Ceará, 60.430-230, Brazil

RECRUITING

Hospital Sírio-Libanês DF

Brasília, Federal District, 70.200-730, Brazil

NOT YET RECRUITING

Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX)

Ipatinga, Minas Gerais, 35.160-158, Brazil

NOT YET RECRUITING

Oncominas - Clínica de Oncologia no Sul de Minas

Pouso Alegre, Minas Gerais, 37.554-216, Brazil

RECRUITING

Real Hospital Português de Beneficência em Pernambuco

Recife, Pernambuco, 50.030-230, Brazil

NOT YET RECRUITING

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, São Paulo, 14.015-010, Brazil

RECRUITING

Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)

Rio de Janeiro, 22.793-080, Brazil

RECRUITING

Hospital Sírio-Libanês SP

São Paulo, 01.308-050, Brazil

RECRUITING

HAOC - Hospital Alemão Oswaldo Cruz

São Paulo, 01.323-020, Brazil

RECRUITING

BP - A Beneficência Portuguesa de São Paulo

São Paulo, 01.323-030, Brazil

RECRUITING

A.C. Camargo Cancer Center

São Paulo, 01.509-001, Brazil

RECRUITING

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Gustavo Nader Marte

    Latin American Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 20, 2023

Study Start

November 9, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations