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Hypofractionated Versus Conventional Fractionation Radiotherapy

10. juli 2019 opdateret af: Hospital da Baleia

Hypofractionated Versus Conventional Fractionation Radiation After Conservative Surgery or Mastectomy With Irradiation of Lymph Node Drainage: a Phase II Randomized Clinical Trial for the Evaluation of Acute Toxicity

This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation.

Eligible breast cancer patients are randomized 1:1 into the following two groups:

  1. Hypofractionated therapy: 40 Gy in 15 fractions of 2.67 Gy in breast or chest wall and nodal drainage with Concurrent boost 48.0 Gy / 3.2 Gy daily in tumor bed, in case of conservative surgery;
  2. Standard fractionation: 50 Gy in 25 fractions in breast or chest wall and nodal drainage with sequential tumor bed boost with 10 Gy in 5 fractions in tumor bed in case of conservative surgery.

Patients will be followed for 6 months after radiotherapy to evaluate acute toxicity and quality of life.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

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

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Female;
  • Older than 18;
  • Breast cancer stage T1 - T3;
  • At least 1 lymph node positive;
  • Treated with mastectomy or conservative surgery;
  • Negative surgical margins;
  • No distant metastasis;
  • No supraclavicular or internal mammary nodes metastases;
  • Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted;
  • Signed informed consent.

Exclusion Criteria:

  • Positive surgical margins;
  • Concomitant chemotherapy;
  • Supraclavicular or internal mammary nodes metastases;
  • Distant metastasis;
  • Previous thoracic radiotherapy;
  • Bilateral breast cancer;
  • Patients with collagen diseases;
  • Unable or unwilling to sign inform consent.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Conventional radiotherapy

50 Gy in 25 fractions to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla), followed by tumor bed boost of 10 Gy in 5 fractions in case of breast conserving surgery.

Total time: 5-6 weeks.
Stråling: Conventional radiotherapy
50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
Andre navne:
  • Standard fractionation
Eksperimentel: Hypofractionated radiotherapy

40 Gy in 15 fractions (2.67 Gy each) to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla).

Patients undergoing breast conserving surgery will receive concomitant boost with total dose of 48 Gy in 15 fractions (3.20 Gy each) to tumor bed.

Total time: 3 weeks.
Stråling: Hypofractionated radiotherapy
40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
Andre navne:
  • Hypofractionated therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CTCAE Toxicity Assessement - Acute Toxicity
Tidsramme: Before treatment, every week of treatment (week 1 to 3 or 1 to 5-6, according to the treatment arm), at the end of treatment (week 3 or week 5-6, according to the treatment arm), 4, 8 and 24 weeks after the last fraction received.
Change in acute toxicity will be assessed according to criteria of CTCAE version 4.03.
Before treatment, every week of treatment (week 1 to 3 or 1 to 5-6, according to the treatment arm), at the end of treatment (week 3 or week 5-6, according to the treatment arm), 4, 8 and 24 weeks after the last fraction received.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life - EORTC QLQ-C30 (version 3)
Tidsramme: Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.
Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3).
Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.
Quality of Life - EORTC breast cancer module (BR23)
Tidsramme: Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.
Patients' quality of life will be assessed using self-administered questionnaire EORTC breast cancer module (BR23).
Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.

Samarbejdspartnere og efterforskere

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

Sponsor

Hospital da Baleia

Efterforskere

  • Ledende efterforsker: Gabriel Oliveira B Gil, MD, Baleia Hospital

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.

Generelle publikationer

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 (Forventet)

1. juli 2019

Primær færdiggørelse (Forventet)

1. maj 2020

Studieafslutning (Forventet)

1. december 2020

Datoer for studieregistrering

Først indsendt

8. august 2016

Først indsendt, der opfyldte QC-kriterier

10. juli 2019

Først opslået (Faktiske)

11. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RT 1901

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Use of a controlled access approach, with a transparent system to review requests and provide secure data access; assurance that patient privacy and confidentiality can be maintained;

IPD-delingstidsramme

From 2020 onwards

IPD-delingsadgangskriterier

Principal investigator's e-mail

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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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