Radiation After No Axillary Nodal Sampling (RADIANS)
20. juli 2026 opdateret af: NYU Langone Health
RADIation After no Axillary Nodal Sampling (RADIANS)
This is a single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
Baseline demographic and clinical information will be collected.
All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years.
All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
105
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: CancerTrials Inbox
- Telefonnummer: 212-731-6000
- E-mail: CancerTrials@nyulangone.org
Studiesteder
-
-
New York
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New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU Langone Health
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Individuals assigned Female at birth, age 40 and older
- Breast conserving surgery without SLNB or ALND
- All patients should be capable of giving informed consent,
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Histologically confirmed invasive ductal carcinoma
- Individuals with pathologic tumor size <3cm
- Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial.
- Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging)
- Electrocorticography (ECOG) performance status 0-2
Exclusion Criteria:
- Male
- Transgender or non-binary individuals.
- Mastectomy
- Metastatic disease
- History of ipsilateral or contralateral breast cancer.
- Obstacles to obtaining informed consent or undergoing regular follow-up
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: Early-Stage Breast Cancer Patients
Patients in whom a sentinel lymph node biopsy is omitted will receive Partial Breast Irradiation (PBI).
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Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of Axillary Recurrence
Tidsramme: Up to Year 5-post-radiation
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Proportion of patients in whom the return of breast cancer in the lymph nodes of the armpit is observed.
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Up to Year 5-post-radiation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of Local Recurrence
Tidsramme: Up to Year 5-post-radiation
|
Proportion of patients in whom the return of breast cancer to the same area as the original tumor is observed.
|
Up to Year 5-post-radiation
|
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Rate of Distant Recurrence
Tidsramme: Up to Year 5-post-radiation
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Proportion of patients in whom the return of breast cancer to a different area from the original tumor is observed.
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Up to Year 5-post-radiation
|
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Breast-Cancer Specific Survival
Tidsramme: Up to Year 5-post-radiation
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Time from initiation of treatment to death attributed to breast cancer.
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Up to Year 5-post-radiation
|
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Overall Survival
Tidsramme: Up to Year 5-post-radiation
|
Time from initiation of treatment to death due to any cause.
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Up to Year 5-post-radiation
|
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Rate of Endocrine Therapy Initiation
Tidsramme: Up to Year 5-post-radiation
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Proportion of patients who initiate endocrine therapy.
|
Up to Year 5-post-radiation
|
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Rate of Endocrine Therapy Adherence
Tidsramme: Up to Year 5-post-radiation
|
Proportion of patients who display adherence to endocrine therapy following initiation.
|
Up to Year 5-post-radiation
|
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Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score
Tidsramme: Baseline, Year 2 Post-Radiation
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BCTOS-13 is a 13-item assessment of aesthetic and functional changes following breast-conserving therapy.
Each item is rated on a Likert scale from 1-4; the total score is the average of the item responses and ranges from 1.0 - 4.0.
Lower scores indicate a better outcome, meaning the patient perceives less difference between the treated and untreated breast
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Baseline, Year 2 Post-Radiation
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Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT)
Tidsramme: Baseline, Year 2 Post-Radiation
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OST-FACIT is a patient-reported questionnaire designed to measure the financial distress and hardship caused by medical treatments for chronic illnesses.
11 items are rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-44.
Higher scores indicate less financial distress.
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Baseline, Year 2 Post-Radiation
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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: Naamit Gerber, MD, NYU Langone Health
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)
9. juli 2026
Primær færdiggørelse (Anslået)
31. juli 2034
Studieafslutning (Anslået)
31. juli 2034
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25-01450
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
No plans to share de-identified IPD with other researchers at this time.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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