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Ultra-hypofractionated Irradiation of the Whole Breast (WBI) Compared to Partial Breast Irradiation (PBI)

27 settembre 2026 aggiornato da: Marko Bojovic, Oncology Institute of Vojvodina

Ultra-hypofractionated Radiotherapy for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial

Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions.

The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery.

If adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy).

The radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. For radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. The clinical target volume (CTV) is delineated according to the recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European Society for Radiotherapy and Oncology (ESTRO).

A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment.

Tipo di studio

Interventistico

Iscrizione (Stimato)

106

Fase

  • Fase 2

Contatti e Sedi

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

Luoghi di studio

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21204
        • Oncology Institute of Vojvodina

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

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Breast-conserving surgery
  • Invasive ductal carcinoma
  • Age ≥ 50
  • Tumor size ≤ 3 cm
  • R0 resection
  • Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
  • pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
  • Hormone receptor status - any
  • Histological grade G1 or G2

Exclusion Criteria:

  • Neoadjuvant systemic therapy
  • TNBC (triple-negative breast cancer)
  • Extensive intraductal component (EIC)
  • Lymphovascular invasion (LVI)
  • associated DCIS > 2.5 cm in size or high nuclear grade

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: Irradiazione parziale del seno
Radiazione: Partial Breast Irradiation

The course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located.
Sperimentale: Irradiazione del seno intero
Radiazione: Ultra-hypofractionated WBI

An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acute Radiation Toxicity
Lasso di tempo: From the start of radiotherapy up to 6 months.

Proportion of participants experiencing acute radiation toxicity, defined as toxicity occurring within 6 months of the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
From the start of radiotherapy up to 6 months.
Late Radiation Toxicity
Lasso di tempo: From 6 months after the start of radiotherapy up to 60 months.

Proportion of participants experiencing late radiation toxicity, defined as toxicity occurring more than 6 months after the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
From 6 months after the start of radiotherapy up to 60 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Local-Regional Recurrence
Lasso di tempo: From adjuvant radiotherapy until locoregional recurrence, assessed up to 10 years.

Time from adjuvant radiotherapy to the first occurrence of pathologically confirmed locoregional tumor recurrence, defined as any newly suspicious skin change(s) or palpable lymph node(s) in the irradiated area. Participants without locoregional recurrence are censored at the date of last follow-up.
From adjuvant radiotherapy until locoregional recurrence, assessed up to 10 years.
Disease-Free Survival (DFS)
Lasso di tempo: From adjuvant radiotherapy until disease recurrence, second primary tumor, or death from any cause, assessed up to 10 years.

Time from adjuvant radiotherapy to the first occurrence of clinically confirmed local recurrence, distant metastasis, second primary tumor, or death from any cause, whichever occurs first. Participants who are alive and disease-free at the time of analysis are censored at the date of last follow-up.
From adjuvant radiotherapy until disease recurrence, second primary tumor, or death from any cause, assessed up to 10 years.
Overall Survival (OS)
Lasso di tempo: From adjuvant radiotherapy until death from any cause, assessed up to 10 years.

Time from adjuvant radiotherapy to death from any cause. Participants who are alive at the time of analysis are censored at the date of last follow-up.
From adjuvant radiotherapy until death from any cause, assessed up to 10 years.
Time to Distant Metastasis
Lasso di tempo: From adjuvant radiotherapy until distant metastasis or death, assessed up to 10 years.

Time from adjuvant radiotherapy to the first occurrence of distant metastasis, confirmed by imaging or pathology. Participants without distant metastasis are censored at the date of last follow-up or death.
From adjuvant radiotherapy until distant metastasis or death, assessed up to 10 years.
Physician-reported Harvard Breast Cosmesis Scale
Lasso di tempo: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.

Cosmesis assessed by the physician using the Harvard Breast Cosmesis Scale. This is a 4-point categorical scale: Excellent (treated breast nearly identical to the untreated breast), Good (slight difference between breasts), Fair (obvious difference between breasts but without major distortion), and Poor (marked distortion of the treated breast). Higher scores (Poor) indicate worse cosmesis. The physician completes the assessment independently.
Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Patient-reported Harvard Breast Cosmesis Scale
Lasso di tempo: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.

Cosmesis assessed by the patient using the Harvard Breast Cosmesis Scale. This is a 4-point categorical scale: Excellent (treated breast nearly identical to the untreated breast), Good (slight difference between breasts), Fair (obvious difference between breasts but without major distortion), and Poor (marked distortion of the treated breast). Higher scores (Poor) indicate worse cosmesis. The patient completes the assessment independently.
Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Quality of Life - EORTC QLQ-C30 (Serbian version)
Lasso di tempo: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.

The Serbian translation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), validated for the Serbian-speaking population, will be used to assess quality of life. This questionnaire consists of 30 items grouped into functional scales, symptom scales, a global health status/QoL scale, and single-item symptom scales. Responses are converted to a 0 to 100 scale. For functional and global QoL scales, higher scores indicate better functioning/QoL. For symptom scales, higher scores indicate greater symptom severity.
Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Quality of Life - EORTC QLQ-BR23 (Serbian version)
Lasso di tempo: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.

The Serbian translation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23), validated for the Serbian-speaking population, will be used to assess breast cancer-specific quality of life. This 23-item module includes functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss). Scores are converted to a 0 to 100 scale. For functional scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom severity.
Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.

Collaboratori e investigatori

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

Sponsor

Oncology Institute of Vojvodina

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)

1 giugno 2023

Completamento primario (Effettivo)

1 giugno 2026

Completamento dello studio (Stimato)

1 giugno 2036

Date di iscrizione allo studio

Primo inviato

8 giugno 2023

Primo inviato che soddisfa i criteri di controllo qualità

19 giugno 2023

Primo Inserito (Effettivo)

22 giugno 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • NS-dojka-SRB

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Descrizione del piano IPD

The analyzed data from the study will be published in scientific journals. We are prepared to share our data for analysis with researchers from similar studies (previously registered on ClinicalTrials.gov) to compare our results.

Periodo di condivisione IPD

The expected time for the publication of the first data is in 3 years (2026).

Criteri di accesso alla condivisione IPD

Contact the researchers via email.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF
  • RSI

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

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

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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