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Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

NCT ID: NCT05665920

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2030-12-31

Brief Summary

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The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.

Detailed Description

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This is a prospective, interventional, exploratory, controlled, randomized study in a 1:1 ratio, to be carried out in a single center, and seeks to evaluate the safety and efficacy of hypofractionated irradiation in women with breast cancer who receive nodal irradiation regional.

Conditions

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Malignant Breast Neoplasm

Keywords

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Dose splitting Acute and late toxicity Locoregional drainage irradiation Breast neoplasm Overall survival Disease-free survival Locoregional control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Whole breast Radiotherapy

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Group Type ACTIVE_COMPARATOR

Standard Radiation

Intervention Type RADIATION

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Ultra-hypofractionated whole breast radiotherapy

Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Group Type EXPERIMENTAL

Ultra-hypofractionated whole breast radiotherapy

Intervention Type RADIATION

Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Interventions

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Ultra-hypofractionated whole breast radiotherapy

Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Intervention Type RADIATION

Standard Radiation

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Information to the patient and signed informed consent;
* Women aged ≥18 years;
* Breast conserving surgery;
* Invasive adenocarcinoma (except classic invasive lobular carcinoma);
* TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;
* Eastern Cooperative Oncology Group (ECOG) 0 -1;
* Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);
* No previous breast or mediastinal radiotherapy;
* No hematogenous metastases;
* Ability to carry out long-term follow-up;

Exclusion Criteria

* Previous local irradiation;
* Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;
* Histology of metaplastic carcinoma;
* History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.
* Diagnosis of autoimmune and connective tissue diseases;
* Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);
* Indication of internal breast irradiation.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Brasileiro de Controle do Cancer

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Barbieri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eduardo Barbieri

Role: PRINCIPAL_INVESTIGATOR

IBCC Oncologia

Locations

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IBCC Oncologia

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Eduardo Barbieri

Role: CONTACT

Phone: +551198639-1945

Email: [email protected]

Alayne Yamada, PhD

Role: CONTACT

Phone: +55114450-0347

Email: [email protected]

Facility Contacts

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Eduardo Barbieri

Role: primary

Alayne Yamada, PhD

Role: backup

Other Identifiers

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60905722.0.0000.0072

Identifier Type: -

Identifier Source: org_study_id