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Hypofraktioneret strålebehandling til behandling af livmoderhals- eller endometriecancer (RT-PACE)

2. september 2026 opdateret af: University of Utah

RT-PACE: Et pilotstudie af adjuverende hypo-fraktioneret strålebehandling til ikke-metastatisk livmoderhals- og endometriecancer

Dette kliniske forsøg undersøger muligheden for at bruge hypofraktioneret strålebehandling til behandling af livmoderhals- eller endometriecancer. Hypofraktioneret strålebehandling giver højere doser af strålebehandling over en kortere periode og kan dræbe flere tumorceller og have færre bivirkninger.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆR MÅL:

I. At fastslå forsøget som muligt og at vurdere indvirkningen på akut gastrointestinal toksicitet i den tredje uge af bækkenstrålebehandling efter et hypofraktioneret skema.

SEKODÆRE MÅL:

I. At vurdere indvirkningen på akut urintoksicitet. II. For at estimere indvirkningen på patientrapporteret gastrointestional toksicitet. III. At vurdere akut livskvalitet efter behandling. IV. At kvantificere akut økonomisk toksicitet efter behandling. V. At vurdere tilfredshed med beslutningstagning efter behandling. VI. At vurdere den samlede overlevelse gennem 3 års opfølgning efter behandling.

OMRIDS:

Patienter gennemgår hypofraktioneret strålebehandling over 3 uger i fravær af sygdomsprogression eller uacceptabel toksicitet.

Efter afslutning af undersøgelsesbehandlingen følges patienterne op efter 1, 3 og 6 måneder og derefter efter 1, 2 og 3 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Forsøgspersoner i alderen >= 18 år
  • Patologisk bekræftet malignitet i livmoderhalsen eller endometriet. Ikke-epiteliale histologier er tilladt. Adenocarcinom in situ er også tilladt
  • Patienter skal have status efter hysterektomi for indledende behandling af livmoderhals- eller endometriecancer
  • Forsøgsperson skal have ikke-metastatisk sygdom som bestemt ved klinisk undersøgelse eller computertomografi (CT) eller positronemissionstomografi (PET)/CT-billeddannelse
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus =< 2
  • Genopretning til baseline eller =< grad 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 fra toksicitet relateret til enhver tidligere cancerbehandling, medmindre den behandlende investigator vurderer det som klinisk ikke signifikant
  • I stand til at give informeret samtykke og villig til at underskrive en godkendt samtykkeformular, der er i overensstemmelse med føderale og institutionelle retningslinjer
  • Forventet levetid på > 2 år
  • Kemoterapi kan administreres efter skøn af den behandlende strålelæge, medicinske eller gynækologiske onkolog. Sekventiel terapi (stråling efterfulgt af kemoterapi) foretrækkes, men er ikke påkrævet

Ekskluderingskriterier:

  • Tidligere abdominal eller bækkenbestråling
  • Interval mellem hysterektomi og planlagt start af strålebehandling på mere end 16 uger, medmindre kemoterapi gives før RT. Hvis kemoterapi administreres før RT, konsulteres PI vedrørende acceptabel tidsramme.
  • Tidligere historie med inflammatorisk tarmsygdom
  • Diagnosen af ​​en anden malignitet inden for =< 2 år før studieindskrivning, undtagen for dem, der anses for at være tilstrækkeligt behandlet uden tegn på sygdom eller symptomer og/eller vil ikke kræve behandling i løbet af undersøgelsens varighed (dvs. basalcelle- eller pladecellehudkræft karcinom in situ i brystet eller blæren eller livmoderhalsen)
  • Medicinske, psykiatriske, kognitive eller andre tilstande efter investigatorens mening, der kan kompromittere forsøgspersonens evne til at forstå emneinformationen, give informeret samtykke, overholde undersøgelsesprotokollen eller fuldføre undersøgelsen

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
Eksperimentel: Behandling (hypofraktioneret strålebehandling)
Patienter gennemgår hypofraktioneret strålebehandling over 3 uger i fravær af sygdomsprogression eller uacceptabel toksicitet.
Stråling: Hypofraktioneret strålebehandling
Gennemgå hypofraktioneret strålebehandling
Andre navne:
  • Hypofraktioneret strålebehandling
  • hypofraktionering
  • Stråling, Hypofraktioneret
  • Hypofraktioneret

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Toxicity - Bowel Summary Score
Tidsramme: from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit

Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score.

Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL).

This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint.
from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit
Trial Feasibility - Number of Evaluable Patients
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit)

To assess the feasibility of administering a clinical trial to evaluate hypofractionated radiotherapy.

This outcome measure will report the number of evaluable patients and the number of patients who started study treatment but were not deemed evaluable. To be considered evaluable, an eligible patient must have completed 3 weeks of treatment and completed EPIC bowel domain questionnaire at baseline and 3 weeks.
Baseline to week 3 (up to 6 weeks from the baseline visit)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Urinary Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

Change in urinary toxicity will be measured by the change in urinary summary score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 10 items in this assessment create the Urine Summary score.

Urine Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Urine Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL).

This outcome measure will report mean EPIC Urine Summary scores at the week 3 and 1 year timepoint.
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Change in Bowel Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument
Tidsramme: Baseline to 1 year (up to 14 months from the baseline visit)

Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score.

Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL).

This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint.
Baseline to 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea)
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.

This outcome measure is a single item assessing how OFTEN participants experienced Loose or Watery Stools (Diarrhea) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.

This outcome measure is a single item assessing how OFTEN participants experienced Pain in the Abdomen (Belly Area) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.

This outcome measure is a single item assessing the SEVERITY of participants' Pain in the Abdomen (Belly Area) at its WORST in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.

This outcome measure is a single item assessing how much Pain in the Abdomen (Belly Area) INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.

This outcome measure is a single item assessing how OFTEN participants experienced Lose Control of Bowel Movement in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments.

This outcome measure is a single item assessing how much Loss of Control of Bowel Movement Interfere INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To assess acute and 1 year quality of life following treatment as assessed on the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx).

FACT-Cx is a 42-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-Cx total scores range from 0-168, with higher scores indicating better Quality of Life (QOL) and lower scores indicating worse QOL This outcome measure will report the mean change in the FACT-Cx Total Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) timpoints.

A positive change indicates the scores increased (improved QOL), and a negative Change indicates the scores decreased (worse QOL).
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Change in FACIT Measure of Financial Toxicity (FACIT-COST) Score
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To assess acute and 1 year quality of life following treatment as assessed on the FACIT Measure of Financial Toxicity (FACIT-COST).

FACT-COST is a 12-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-COST Score ranges from 0-44, with higher scores indicating better financial well-being and lower scores indicating worse financial well-being. This outcome measure will report the mean change in the FACT-COST Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points.

A positive change indicates the scores increased (better financial well-being), and a negative Change indicates the scores decreased (worse financial well-being).
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Decision Regret Scale - Summary Score
Tidsramme: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To assess acute and 1 year satisfaction with decision-making following treatment.

The Decision Regret Scale is a 5-item, self-assessed questionnaire rated on a 5-point Likert scale. Decision Regret Scale Score ranges from 0-100, with higher scores indicating high regret and lower scores indicating less regret.

This outcome measure will report the mean Decision Regret Scale Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points.
Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Overall Survival
Tidsramme: Time to the earliest of all-cause mortality (event), end of study follow-up (censoring criteria), or loss to follow-up (censoring criteria), assessed up to 3 years
Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment.
Time to the earliest of all-cause mortality (event), end of study follow-up (censoring criteria), or loss to follow-up (censoring criteria), assessed up to 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Utah

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Gita Suneja, MD, Huntsman Cancer Institute

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)

11. november 2021

Primær færdiggørelse (Faktiske)

17. juli 2024

Studieafslutning (Anslået)

26. juni 2027

Datoer for studieregistrering

Først indsendt

18. november 2021

Først indsendt, der opfyldte QC-kriterier

18. november 2021

Først opslået (Faktiske)

1. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 144462
  • P30CA042014 (U.S. NIH-bevilling/kontrakt)
  • HCI144462 (Anden identifikator: Huntsman Cancer Institute/University of Utah)
  • NCI-2021-12258 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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