Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2026-06-30

Brief Summary

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An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.

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Detailed Description

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PRIMARY OBJECTIVE:

I. Compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery.

SECONDARY OBJECTIVES:

I. Identify the histological lineage of the tumor.

II. Identify the degree of differentiation of tumor cells.

III. Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry.

IV. Measure the frequency of progression or recurrence.

V. Identify the site of progression or recurrence.

VI. Measure the frequency of toxicity in both groups.

VII. Classify toxicity according to its severity.

VIII. Classify toxicity according to chronological presentation, acute, subacute, or chronic.

IX. Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale, Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23).

X. Measure quality of life in both groups according to the Eastern Collaborative Oncology Group (ECOG) performance scale.

XI. Measure 5-year survival.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: will receive radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.

ARM II: will receive radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients.

After completion of treatments, patients will be followed: 2 weeks after final fraction, 6 weeks after final fraction, every 4 months for the next 5 years

Conditions

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Ductal Breast Carcinoma in Situ Invasive Breast Cancer Early-stage Breast Cancer Stage 0 Breast Cancer Stage I Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARM I

Radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.

Group Type EXPERIMENTAL

Hypofractionated radiotherapy

Intervention Type RADIATION

Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.

ARM II

Radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients.

Group Type ACTIVE_COMPARATOR

Hypofractionated radiotherapy

Intervention Type RADIATION

Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.

Interventions

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Hypofractionated radiotherapy

Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.

Intervention Type RADIATION

Other Intervention Names

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Adjuvant Radiation Therapy External Beam Radiotherapy 3D Conformal Radiation Therapy Intensity Modulated Radiation Therapy IMRT Fixed Gantry Radiation Therapy Hypofractionated Whole Breast Irradiation Quality of Life Questionnaire: EORTC QLQ-BR23

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma.
* Treated with breast-conserving surgery and stage pT1-2 pN0 M0.
* Over 18 years.
* Patients who sign informed consent for research study.