Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

November 7, 2022 updated by: Patricia Berenice Bolado Garcia, Coordinación de Investigación en Salud, Mexico

Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Yucatán
      • Mérida, Yucatán, Mexico, 97150
        • Recruiting
        • Unidad Medica de Alta Especialidad
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando H Castillo-Lopez, Phy.
        • Sub-Investigator:
          • Jose L Reyes-Leon, Phy.
        • Sub-Investigator:
          • Emma M Melgoza-Alcorta, Phy.
        • Principal Investigator:
          • Patricia B Bolado-Garcia, MD.
        • Sub-Investigator:
          • Juan M Pech-Leon, Phy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ARM I
Radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.
Radiation: Hypofractionated radiotherapy
Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.
Other Names:
  • External Beam Radiotherapy
  • Intensity Modulated Radiation Therapy
  • Adjuvant Radiation Therapy
  • 3D Conformal Radiation Therapy
  • IMRT Fixed Gantry Radiation Therapy
  • Hypofractionated Whole Breast Irradiation
  • Quality of Life Questionnaire: EORTC QLQ-BR23
ACTIVE_COMPARATOR: 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.
Radiation: Hypofractionated radiotherapy
Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.
Other Names:
  • External Beam Radiotherapy
  • Intensity Modulated Radiation Therapy
  • Adjuvant Radiation Therapy
  • 3D Conformal Radiation Therapy
  • IMRT Fixed Gantry Radiation Therapy
  • Hypofractionated Whole Breast Irradiation
  • Quality of Life Questionnaire: EORTC QLQ-BR23

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the progression timing.
Time Frame: 5 years
Quantify the time to progression through follow up in both groups
5 years
Identify the recurrence timing.
Time Frame: 5 years
Quantify the time to recurrence through follow up in both groups
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the histological lineage of the tumor
Time Frame: 14 Months

Carcinoma InSitu or Invasive Carcinoma;

  1. - Adenocarcinoma
  2. - Other
14 Months
Identify the degree of differentiation of tumor cells
Time Frame: 14 months

Histologic grade identification using Scarff-Bloom-Richardson (SBR) scale

  1. Grade 1: 3-5 points
  2. Grade 2: 6-7 points
  3. Grade 3: 8-9 points
14 months
Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry
Time Frame: 14 months

Number of participants with presence of Luminal A, B, HER-2NEU enriched or triple negative immunohistochemistry subtype.

  1. Luminal A: RE (+), RP >20%, Ki67 <20% y HER 2 NEU (-)
  2. Luminal B: RE (+), RP <20%, Ki67 >20% y HER 2 NEU (+/-)
  3. HER-2 Enriched: RE (-), RP (-),Ki67 any, HER 2 NEU (+)
  4. Triple Negative: RE (-), RP (-), Ki67 any, HER-2 (-)
14 months
Measure the frequency of toxicity in both groups.
Time Frame: 5 years

Quantify the presence of toxicity categorized by CTCAE version 5 system.

  1. Grade 1: characterized by the presence of a mild adverse event that does not require treatment
  2. Grade 2: considers a moderate adverse event that may require medical treatment on an outpatient basis
  3. Grade 3: is a serious adverse event that should receive medical treatment, and even hospital treatment.
  4. Grade 4: is an adverse event with risk of death or disability that requires specialized medical management and hospitalization.
  5. Grade 5: considers the presence of death associated with an adverse event.
5 years
Classify toxicity according to its severity.
Time Frame: 5 years

Quantify toxicity according to its severity categorized by CTCAE version 5 system.

  1. Dry skin: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture

    - Grade 1 to 3

  2. Eczema: A disorder characterized by skin which becomes itchy, red, inflamed, crusty, thick, scaly, and/or forms blisters.

    - Grade 1 to 3

  3. Skin hyperpigmentation: A disorder characterized by darkening of the skin due to excessive melanin deposition.

    - Grade 1 to 2

  4. Dysphagia: A disorder characterized by difficulty in swallowing.

    - Grade 1 to 4

  5. Cough: A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound.

    - Grade 1 to 3

  6. Pneumonitis: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.

    • Grade 1 to 5
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23).
Time Frame: 5 Years
Quantify quality of life with QLQ-BR23 questionnaire created by the European Organization for Research and Treatment of Cancer Group
5 Years
Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale (ECOG)
Time Frame: 5 Years
Quantify quality of life with Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Investigators

  • Principal Investigator: Fernando H Castillo-Lopez, Phy., Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 26, 2021

Primary Completion (ANTICIPATED)

March 30, 2026

Study Completion (ANTICIPATED)

June 30, 2026

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (ACTUAL)

April 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2021-3203-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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