Ultra-hypofractionated Irradiation of the Whole Breast (WBI) Compared to Partial Breast Irradiation (PBI)
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Vojvodina
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Novi Sad, Vojvodina, Serbia, 21204
- Oncology Institute of Vojvodina
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: Irradiación mamaria parcial
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The course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located. |
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Experimental: Irradiación de mama completa
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An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute Radiation Toxicity
Periodo de tiempo: From the start of radiotherapy up to 6 months.
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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.
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Late Radiation Toxicity
Periodo de tiempo: From 6 months after the start of radiotherapy up to 60 months.
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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.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to Local-Regional Recurrence
Periodo de tiempo: From adjuvant radiotherapy until locoregional recurrence, assessed up to 10 years.
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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.
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Disease-Free Survival (DFS)
Periodo de tiempo: From adjuvant radiotherapy until disease recurrence, second primary tumor, or death from any cause, assessed up to 10 years.
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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.
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Overall Survival (OS)
Periodo de tiempo: From adjuvant radiotherapy until death from any cause, assessed up to 10 years.
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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.
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Time to Distant Metastasis
Periodo de tiempo: From adjuvant radiotherapy until distant metastasis or death, assessed up to 10 years.
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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.
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Physician-reported Harvard Breast Cosmesis Scale
Periodo de tiempo: 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.
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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.
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Patient-reported Harvard Breast Cosmesis Scale
Periodo de tiempo: 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.
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Quality of Life - EORTC QLQ-C30 (Serbian version)
Periodo de tiempo: 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.
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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.
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Quality of Life - EORTC QLQ-BR23 (Serbian version)
Periodo de tiempo: 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.
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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.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- NS-dojka-SRB
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
The expected time for the publication of the first data is in 3 years (2026).
Criterios de acceso compartido de IPD
Contact the researchers via email.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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