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Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery (LAPIDARY)

4 marzo 2021 aggiornato da: Eduardo Barbieri, Instituto Brasileiro de Controle do Cancer

Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery

Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.

There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

36

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Eduardo Barbieri
  • Numero di telefono: +551198639-1945
  • Email: edurxt@gmail.com

Backup dei contatti dello studio

Luoghi di studio

  • Brasile
    • SP
      • Sao Paulo, SP, Brasile, 03102-002
        • Reclutamento
        • IBCC Oncologia
        • Contatto:
          • Eduardo Barbieri
          • Numero di telefono: +55 11 98639-1945
          • Email: edurxt@gmail.com
        • Investigatore principale:
          • Eduardo Barbieri
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Information to the patient and signed informed consent;
  • Women aged ≥50 years
  • Breast conserving surgery
  • Pathologic tumor size < 3 cm (maximum microscopic diameter of the invasive component)
  • Invasive adenocarcinoma (except classic invasive lobular carcinoma)
  • Unifocal disease
  • Histopathologic grades I or II
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Lymphovascular invasion absent
  • Negative axillary lymph nodes
  • Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
  • No prior breast or mediastinal radiotherapy
  • No hematogenous metastases

Exclusion Criteria:

  • Previous malignancy (except non-melanomatous skin cancer)
  • Mastectomy
  • Classical-Type Invasive Lobular Carcinoma
  • Neoadjuvant chemotherapy
  • Human Epidermal growth factor Receptor-type 2 positive (HER2+)
  • Triple-negative breast cancers
  • Intravascular lymphoma present
  • Contraindications to radiotherapy.
  • No geographical, social or psychologic reasons that would prevent study follow

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Active Comparator: Standard
Whole breast Radiotherapy, 40 Gray (40Gy) fractions
Radiazione: Active Comparator: Standard
Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
Sperimentale: Experimental 1: Hypofractionated radiotherapy
Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
Radiazione: Experimental 1: Hypofractionated radiotherapy
Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
Sperimentale: Experimental 2: Accelerated Partial Breast Irradiation
Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.
Radiazione: Experimental 2: Accelerated Partial Breast Irradiation
Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of local recurrence
Lasso di tempo: 5 years
To estimate and compare the rate of local recurrence between the experimental and control arms.
5 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to occurrence of distant metastases
Lasso di tempo: 5 years
Distant tumor time is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up.
5 years
Disease-free survival
Lasso di tempo: 5 years
Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
5 years
Overall survival
Lasso di tempo: 5 years
Overall survival time, defined as number of days from randomization until death or end of follow-up.
5 years
Medico-economic study
Lasso di tempo: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Health-related Quality of Life
Lasso di tempo: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patients quality of life with the help of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts. The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Evaluation of quality of life change by European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
Lasso di tempo: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)
Lasso di tempo: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life with the help of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F). Scores are interpreted according to the guidelines of the Scoring Manual. The higher the number of points, the better the quality of life. To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Measurement Satisfaction of Body Image of the participants
Lasso di tempo: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS). Scores are interpreted according to the guidelines of the Scoring Manual. The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Changes in anxiety and depression
Lasso di tempo: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life and patient satisfaction with the help of the Hospital Anxiety and Depression Scale (HADS). Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
Early and late adverse effects in normal tissues
Lasso di tempo: 5 years
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
5 years
Late adverse effects
Lasso di tempo: 5 years
To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.
5 years
Acute toxicity rate
Lasso di tempo: 5 years
To evaluate acute toxicity rate. The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using Common Terminology Criteria for Adverse Events.
5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Instituto Brasileiro de Controle do Cancer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 marzo 2021

Completamento primario (Anticipato)

7 dicembre 2025

Completamento dello studio (Anticipato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

4 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

9 dicembre 2020

Primo Inserito (Effettivo)

17 dicembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 marzo 2021

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 38341220.8.0000.0072

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

The findings will be shared and discussed with all investigators in the study. A study manuscript, having received contributions from all authors, will be submitted for publication in scientific circles.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

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Sedi

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