Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

Sponsor
Coordinación de Investigación en Salud, Mexico (Other)
Overall Status
Recruiting
CT.gov ID
NCT05318274
Collaborator
(none)
72
1
2
23.1
3.1

Study Details

Study Description

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. Identify the histological lineage of the tumor.

  2. Identify the degree of differentiation of tumor cells.

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

  4. Measure the frequency of progression or recurrence.

  5. Identify the site of progression or recurrence.

  6. Measure the frequency of toxicity in both groups.

  7. Classify toxicity according to its severity.

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

  9. 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).

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

  11. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.
Actual Study Start Date :
Apr 26, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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:
  • 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
  • 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:
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. Identify the progression timing. [5 years]

      Quantify the time to progression through follow up in both groups

    2. Identify the recurrence timing. [5 years]

      Quantify the time to recurrence through follow up in both groups

    Secondary Outcome Measures

    1. Identify the histological lineage of the tumor [14 Months]

      Carcinoma InSitu or Invasive Carcinoma; - Adenocarcinoma - Other

    2. Identify the degree of differentiation of tumor cells [14 months]

      Histologic grade identification using Scarff-Bloom-Richardson (SBR) scale Grade 1: 3-5 points Grade 2: 6-7 points Grade 3: 8-9 points

    3. Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry [14 months]

      Number of participants with presence of Luminal A, B, HER-2NEU enriched or triple negative immunohistochemistry subtype. Luminal A: RE (+), RP >20%, Ki67 <20% y HER 2 NEU (-) Luminal B: RE (+), RP <20%, Ki67 >20% y HER 2 NEU (+/-) HER-2 Enriched: RE (-), RP (-),Ki67 any, HER 2 NEU (+) Triple Negative: RE (-), RP (-), Ki67 any, HER-2 (-)

    4. Measure the frequency of toxicity in both groups. [5 years]

      Quantify the presence of toxicity categorized by CTCAE version 5 system. Grade 1: characterized by the presence of a mild adverse event that does not require treatment Grade 2: considers a moderate adverse event that may require medical treatment on an outpatient basis Grade 3: is a serious adverse event that should receive medical treatment, and even hospital treatment. Grade 4: is an adverse event with risk of death or disability that requires specialized medical management and hospitalization. Grade 5: considers the presence of death associated with an adverse event.

    5. Classify toxicity according to its severity. [5 years]

      Quantify toxicity according to its severity categorized by CTCAE version 5 system. 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 Eczema: A disorder characterized by skin which becomes itchy, red, inflamed, crusty, thick, scaly, and/or forms blisters. - Grade 1 to 3 Skin hyperpigmentation: A disorder characterized by darkening of the skin due to excessive melanin deposition. - Grade 1 to 2 Dysphagia: A disorder characterized by difficulty in swallowing. - Grade 1 to 4 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 Pneumonitis: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma. Grade 1 to 5

    Other Outcome Measures

    1. Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23). [5 Years]

      Quantify quality of life with QLQ-BR23 questionnaire created by the European Organization for Research and Treatment of Cancer Group

    2. Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale (ECOG) [5 Years]

      Quantify quality of life with Eastern Cooperative Oncology Group (ECOG) Performance Status Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Unidad Medica de Alta Especialidad Mérida Yucatán Mexico 97150

    Sponsors and Collaborators

    • Coordinación de Investigación en Salud, Mexico

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patricia Berenice Bolado Garcia, MD., Coordinación de Investigación en Salud, Mexico
    ClinicalTrials.gov Identifier:
    NCT05318274
    Other Study ID Numbers:
    • R-2021-3203-005
    First Posted:
    Apr 8, 2022
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2022