Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

Coordinación de Investigación en Salud, Mexico

Status: Enrolling

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

Treatments: Radiation: Hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05318274

R-2021-3203-005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 72 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Positive nodes.
• Clinical or pathological stage T3-T4.
• History of previous irradiation.
• Postoperative positive margin.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

ARM I

Experimental group

Description:

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

Treatment:

Radiation: Hypofractionated radiotherapy

ARM II

Active Comparator group

Description:

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.

Treatment:

Radiation: Hypofractionated radiotherapy