Evaluer effektiviteten og toksiciteten af adjuverende ultrahypofraktioneret strålebehandling til brystkræft
2. april 2024 opdateret af: Prevent Senior Institute
Fase II-undersøgelse til evaluering af effektiviteten og toksiciteten af adjuverende ultrahypofraktioneret strålebehandling til behandling af tidlig og lokalt fremskreden brystkræft
Prospektiv fase 2-undersøgelse til evaluering af sikkerheden og effektiviteten af ultrahypofraktioneret adjuverende strålebehandling i 5 fraktioner af 5,7 Gy hos patienter over 65 år.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Prospektiv fase 2 ikke-randomiseret enkeltarmsundersøgelse til evaluering af sikkerheden og effektiviteten af ultrahypofraktioneret adjuverende strålebehandling i 5 fraktioner af 5,7 Gy hos patienter over 65 år.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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São Paulo, Brasilien
- Instituto de Pesquisa Prevent Senior
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- kvindelig patient;
- Patologisk bekræftelse af invasivt brystcarcinom uanset histologisk subtype og hormonprofil;
- Alder større end eller lig med 65 år;
- Brystbevarende operation eller mastektomi med eller uden aksillær tilgang
- Med eller uden neoadjuverende eller adjuverende systemisk behandling
Ekskluderingskriterier:
- Patienter med tidligere thoraxbestråling;
- Patienter med indikation for bilateral thoraxbestråling;
- Patienter med brystrekonstruktion med protese eller autologt væv;
- Patienter med kompromitterede kirurgiske marginer efter resektion;
- pT1-pT2 pN0 patienter, der gennemgår radikal mastektomi.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Enkeltarm Ultra-hypofraktioneret
5 fraktioner af 5,7 Gy hver anden dag i bryst- eller brystvægsregionen, med eller uden inklusion af regionale lymfeknude-dræningskæder
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adjuverende ultrahypofraktioneret strålebehandling til behandling af tidlig og lokalt fremskreden brystkræft
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Akut forgiftning
Tidsramme: Hændelser af strålebehandling op til 3 måneder
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Akut hudtoksicitet blev evalueret, kriterierne fulgte Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0
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Hændelser af strålebehandling op til 3 måneder
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Sen toksicitet
Tidsramme: Hændelser efter 3 måneders afslutning af strålebehandling
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Forsinkede hud- og subkutane toksiciteter blev evalueret i henhold til klassifikationen Radiation Therapy Oncology Group (RTOG).
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Hændelser efter 3 måneders afslutning af strålebehandling
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Lokoregional fri overlevelse
Tidsramme: 3 år
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fra datoen for påbegyndelse af behandlingen indtil datoen for tilbagefald eller progression af lokoregional sygdomsbevis
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3 år
|
|
Fjern fri overlevelse
Tidsramme: 3 år
|
fra datoen for påbegyndelse af behandlingen indtil datoen for progression af fjerntliggende sygdomsbevis
|
3 år
|
|
Samlet overlevelse
Tidsramme: 3 år
|
defineret fra datoen for påbegyndelse af behandlingen til patientens død
|
3 år
|
|
Kosmesis ændring
Tidsramme: uge 10 og uge 26 efter endt behandling
|
blev vurderet ved hjælp af Harvard/NSABP/RTOG-skalaen. Harvard/NSABP/RTOG-skalaens score er en 4-punkts kosmetisk brystskala, som blev vurderet af klinikere ved baseline (efter operation) og yderligere to gange under opfølgning.
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uge 10 og uge 26 efter endt behandling
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QOL (Quality of Life) ændringer
Tidsramme: 3 år
|
blev vurderet ved hjælp af skalaerne foreslået af EORTC (European Organisation for Research and Treatment of Cancer). EORTC QOQ-C30 og EORTC QLQ-BR-23 vægte. Alle skalaer og enkeltelementmål varierer i score fra 0 til 100. En høj skala-score repræsenterer et højere svarniveau. En høj score for en funktionel skala repræsenterer således et højt / sundt funktionsniveau, en høj score for den globale sundhedsstatus / QoL repræsenterer en høj QoL, men en høj score for en symptomskala / element repræsenterer et højt niveau af symptomatologi / problemer . |
3 år
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Brystvolumen og toksicitetsforhold
Tidsramme: 3 år
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Vi analyserede indvirkningen af CTV (Clinical Target Volume) volumen (repræsenterer bryststørrelse) og dosimetriske data med særligt fokus på den maksimale dosis og dosis i homogenitet (defineret som de absolutte volumener af brystvæv udsat for ≥100 %, ≥ 104 % og ≥107 % af den ordinerede dosis
|
3 år
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Marcel MF Fang, MD, Instituto de Pesquisa Prevent Senior
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. januar 2019
Primær færdiggørelse (Faktiske)
11. februar 2021
Studieafslutning (Faktiske)
1. april 2023
Datoer for studieregistrering
Først indsendt
20. april 2023
Først indsendt, der opfyldte QC-kriterier
30. april 2023
Først opslået (Faktiske)
9. maj 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. april 2024
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. april 2024
Sidst verificeret
1. april 2024
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