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Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule

3. oktober 2014 opdateret af: Gustavo Viani Arruda

Randomized Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule.

There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data from retrospective studies show that IMRT reduces the risk of severe late complications. More recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in reducing acute toxicity for prostate cancer treated with conventional dose escalation. Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a hypofractionated schedule in prostate cancer, the investigators developed a RCT.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

220

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Brasilien
    • Sao Paulo
      • Marilia, Sao Paulo, Brasilien
        • Faculty of Medicine of Marilia

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Patients with diagnosis of prostate cancer
  • With age between 18-75 years classified in low
  • Intermediate and high-risk group according to their Gleason score
  • T stage and initial PSA (iPSA).
  • Low risk group included patients with Gleason score <7 / stage T1-T2a, and iPSA <10 ng/mL.
  • Intermediate risk included Gleason score < 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL
  • High-risk patients with Gleason score >7, or Stage > T2b, or iPSA >20 ng/mL.
  • All patients classified as high risk was submitted to the bone scans.

Exclusion Criteria:

  • Patients with metastases
  • Prior history of prostatectomy
  • Pelvic radiotherapy treatment
  • Chemotherapy treatment were excluded of this trial.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IMRT- Hypofractionated schedule 70 Gy/25 fx
The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.
Stråling: IMRT

The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.

The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.

Andre navne:
  • 3DCRT
Aktiv komparator: 3DCRT-Hypofractionated schedule 70 Gy/25 fx
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy. By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.
Stråling: IMRT

The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.

The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.

Andre navne:
  • 3DCRT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gastrointestinal and geniturinary acute toxicity
Tidsramme: 6 months
The primary study outcome was acute treatment reactions from the beginning of treatment to 6 months after the end of treatment. Patients were seen weekly, or as required, during treatment by a radiation oncologist. Acute gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.
6 months
Gastrointestinal and geniturinary late toxicity
Tidsramme: 24 months
Any toxicity developed after 6 months from radiotherapy treatment was considered as late toxicity. Late gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder.
24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biochemical control
Tidsramme: 3 years
The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.
3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Gustavo Viani Arruda

Efterforskere

  • Ledende efterforsker: Gustavo Viani, PhD, FAMEMA

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

1. januar 2009

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

29. september 2014

Først indsendt, der opfyldte QC-kriterier

3. oktober 2014

Først opslået (Skøn)

6. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FAMEMA-0913

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 .

Kliniske forsøg med IMRT

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Betingelser

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Placeringer

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