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

87
On Track

Trial Health Score

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

Enrollment
461

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

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
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

March 8, 2023

Last Update Submit

August 26, 2026

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

Location

Hospital Sírio-Libanês DF

Brasília, Federal District, 70.200-730, Brazil

Location

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

Ipatinga, Minas Gerais, 35.160-158, Brazil

Location

Oncominas - Clínica de Oncologia no Sul de Minas

Pouso Alegre, Minas Gerais, 37.554-216, Brazil

Location

Real Hospital Português de Beneficência em Pernambuco

Recife, Pernambuco, 50.030-230, Brazil

Location

Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)

Rio de Janeiro, Rio de Janeiro, 22.793-080, Brazil

Location

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

Ribeirão Preto, São Paulo, 14.015-010, Brazil

Location

Hospital Sírio-Libanês SP

São Paulo, São Paulo, 01.308-050, Brazil

Location

HAOC - Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, 01.323-020, Brazil

Location

BP - A Beneficência Portuguesa de São Paulo

São Paulo, São Paulo, 01.323-030, Brazil

Location

A.C. Camargo Cancer Center

São Paulo, São Paulo, 01.509-001, Brazil

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Gustavo Nader Marte

    Latin American Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

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

September 2, 2024

Study Completion

September 2, 2024

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations