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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
-
-
Vojvodina
-
Novi Sad, Vojvodina, Srbsko, 21204
- Oncology Institute of Vojvodina
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Částečné ozařování prsou
|
The course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located. |
|
Experimentální: Ozáření celých prsou
|
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Acute Radiation Toxicity
Časové okno: 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
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Local-Regional Recurrence
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- NS-dojka-SRB
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení IPD
The expected time for the publication of the first data is in 3 years (2026).
Kritéria přístupu pro sdílení IPD
Contact the researchers via email.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .