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| ID | Type | Description | Link |
|---|---|---|---|
| 1012 | Registry Identifier | NNGYK |
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To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.
Accelerated Partial Breast Irradiation (APBI) has demonstrated the non-inferiority compared to external beam radiotherapy (EBRT) in the conserving-treatment of early breast carcinoma by using high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIBT). The standard treatment regimen is 7-8 sessions with two treatments per day, for a total treatment time of 4-5 days. Based on 5-year results of the Groupe Européen de Curiethérapie European SocieTy for Radiotherapy & Oncology (GEC-ESTRO) Very Accelerated Partial Breast Irradiation (VAPBI) phase I-II trial, in low-risk cases, 3-4 fractions delivered in 2 days reduced the overall treatment time with low rate of side effects and excellent oncological outcome.
Retrospective and prospective studies with a single fraction HDR MIBT-based VAPBI suggest that by further increasing the dose delivered in one fraction, the total treatment time can be reduced to a single session safely.
A phase II multicenter trial is proposed to confirm this hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-fraction very accelerated partial breast irradiation arm | Experimental | Low risk, early-stage breast cancer patients, who receiving single-fraction very accelerated partial breast irradiation, as postoperative radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single-fraction very accelerated partial breast irradiation | Radiation | Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction. |
| Measure | Description | Time Frame |
|---|---|---|
| Five-year incidence of late grade ≥ 2 side effects | Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse). | From the third month of treatment to the end of the fifth year of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence (5-year actuarial rate) of ipsilateral breast recurrence (IBR) | From treatment to the end of the fifth year of follow-up. | |
| Incidence (5-year actuarial rate) of regional relapse (RR) | From treatment to the end of the fifth year of follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
We can only treat female breast cancer patients with this technique.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viktor Smanykó, MD | Contact | +3612248600 | 3440 | smanyko.viktor@oncol.hu |
| Name | Affiliation | Role |
|---|---|---|
| Viktor Smanykó, MD | National Institute of Oncology, Budapest, Hungary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Not yet recruiting | Lyon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33831490 | Background | Hannoun-Levi JM, Montagne L, Sumodhee S, Schiappa R, Boulahssass R, Gautier M, Gal J, Chand ME. APBI Versus Ultra-APBI in the Elderly With Low-Risk Breast Cancer: A Comparative Analysis of Oncological Outcome and Late Toxicity. Int J Radiat Oncol Biol Phys. 2021 Sep 1;111(1):56-67. doi: 10.1016/j.ijrobp.2021.03.052. Epub 2021 Apr 6. | |
| 38460552 |
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3-letter abbreviation of the city of the treating hospital. Identification number of the treated patient. Performance score. Detailed histological characteristics of the breast cancer. Data of surgery and brachytherapy. Dosimetrical data. Cosmesis. Side effects. Oncological outcomes.
From treatment to the end of the 5-year follow-up period
The data will be accessible to the study leader and the mathematician who prepares the statistics. The data will be transmitted encrypted to the data processing center.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 19, 2025 |
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| Incidence (5-year actuarial rate) of contralateral breast cancer (CBC) | From treatment to the end of the fifth year of follow-up. |
| Incidence (5-year actuarial rate) of distant metastasis (DM) | From treatment to the end of the fifth year of follow-up. |
| Incidence (5-year actuarial rate) of any relapse (local, regional or distant, whichever came first) for disease free survival (DFS) | From treatment to the end of the fifth year of follow-up. |
| Incidence (5-year actuarial rate) of breast cancer death for cause specific survival (CSS) | From treatment to the end of the fifth year of follow-up. |
| Incidence (5-year actuarial rate) of death by any cause for overall survival (OS) | From treatment to the end of the fifth year of follow-up. |
| Incidence of acute side effects | Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse). | From treatment to the end of the first 3 months of follow-up. |
| Cosmetic results at 5 years | Cosmetic results based on the Harvard criteria (excellent, good, fair, poor). | From treatment to the end of the fifth year of follow-up. |
| Quality of Life (QoL) | European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life questionnaire (QLQ) C30 questionaire including the Breast cancer module (QLQ-BR23) (53 questions in total, from 1 to 4 points, higher score worse) | From treatment to the end of the fifth year of follow-up. |
| Institut de Cancérologie de Lorraine | Not yet recruiting | Nancy | France |
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| Antoine Lacassagne Cancer Centre | Not yet recruiting | Nice | France |
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| Klinikum Bremerhaven | Not yet recruiting | Bremerhaven | Germany |
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| University Hospital Erlangen | Not yet recruiting | Erlangen | Germany |
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| Universitätsklinikum Schleswig-Holstein | Not yet recruiting | Lübeck | Germany |
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| Sana Klinikum Offenbach | Not yet recruiting | Offenbach | Germany |
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| Universitätsklinikum Würzburg | Not yet recruiting | Würzburg | Germany |
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| National Institute of Oncology | Recruiting | Budapest | Hungary |
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| National Cancer Institute | Not yet recruiting | Vilnius | Lithuania |
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| Maria Skłodowska-Curie Bialystok Oncology Center | Not yet recruiting | Bialystok | Poland |
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| Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny | Not yet recruiting | Brzozów | Poland |
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| National Institute of Oncology | Not yet recruiting | Gliwice | Poland |
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| Greater Poland Cancer Centre | Not yet recruiting | Poznan | Poland |
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| Lower Silesian Oncology, Pulmonology and Hematology Center | Not yet recruiting | Wroclaw | Poland |
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| Instituto Português de Oncologia do Porto | Not yet recruiting | Porto | Portugal |
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| Oncology Institute Vojvodina | Not yet recruiting | Kamenica | Serbia |
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| Fundacion IMOR's Oncology Clinic | Not yet recruiting | Barcelona | Spain |
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| Institut Catala d'Oncologia | Not yet recruiting | Barcelona | Spain |
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| Hospital Universitario de Navarra | Not yet recruiting | Pamplona | Spain |
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| Instituto Valenciano de Oncologia | Not yet recruiting | Valencia | Spain |
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| Inselspital, Universitätsspital Bern | Not yet recruiting | Bern | Switzerland |
|
| Hannoun-Levi JM, Gimeno Morales M, Gal J, Anchuelo J, Guinot JL, Gaztanaga M, Meszaros N, Polgar C, Strnad V, Schiappa R, Gutierrez C. Very accelerated partial breast irradiation in 1 or 2 days: Late toxicity and early oncological outcome of the GEC-ESTRO VAPBI cohort. Radiother Oncol. 2024 May;194:110217. doi: 10.1016/j.radonc.2024.110217. Epub 2024 Mar 8. |
| 31767533 | Background | Hannoun-Levi JM, Lam Cham Kee D, Gal J, Schiappa R, Hannoun A, Fouche Y, Gautier M, Boulahssass R, Chand ME. Accelerated partial breast irradiation in the elderly: 5-Year results of the single fraction elderly breast irradiation (SiFEBI) phase I/II trial. Brachytherapy. 2020 Jan-Feb;19(1):90-96. doi: 10.1016/j.brachy.2019.10.007. Epub 2019 Nov 23. |
| 39321957 | Background | Guinot JL, Gutierrez-Miguelez C, Meszaros N, Gonzalez-Perez V, Santos MA, Najjari D, Slocker A, Major T, Polgar C. Five-year results of the very accelerated partial breast irradiation VAPBI phase I-II GEC-ESTRO trial. Radiother Oncol. 2024 Dec;201:110543. doi: 10.1016/j.radonc.2024.110543. Epub 2024 Sep 24. |
| 36738756 | Background | Strnad V, Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Fietkau R, Schlamann A, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Dunst J, Gall C, Uter W; Groupe Europeen de Curietherapie and European Society for Radiotherapy and Oncology. Accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy compared with whole-breast irradiation with boost for early breast cancer: 10-year results of a GEC-ESTRO randomised, phase 3, non-inferiority trial. Lancet Oncol. 2023 Mar;24(3):262-272. doi: 10.1016/S1470-2045(23)00018-9. Epub 2023 Feb 1. |
| Jul 5, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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