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Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery

30. januar 2019 opdateret af: Yu Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery

This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary:

To determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving surgery.

Secondary:

To determine the short term cosmetic and quality of life of the participants treated with this regimen.

To determine the local control of the participants treated with this regimen.

OUTLINE: Patients undergo adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost once daily a week for 3 weeks. Toxicity, quality of life and cosmetic result is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after completion of radiotherapy, and then every 3 months for 1 ear.

PROJECTED ACCRUAL: A total of 90 participants will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100021
        • National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • female, aged between 18-70
  • pathological confirmed breast invasive carcinoma
  • patients after breast lumpectomy(including quadrantectomy) with axillary lymph nodes dissection or sentinel node biopsy
  • stage p T 1-2 N 0
  • metastasis omitted by routine examinations in 1 months before enrollment
  • complete blood count obtained in 2 weeks prior to study entry should meet the following criteria: absolute neutrophil count > 1.8 *10^9/L, hemoglobin > 8.0g/dl, platelet > 75 * 10^9/L
  • hepatic and renal function in 2 weeks prior to study entry should be normal
  • study entry within 60 days from whichever comes later: surgery or last chemotherapy
  • women of childbearing potential must have a negative urine or serum pregnancy test with 2 weeks of study entry
  • signs study specific informed consent prior to study entry

Exclusion Criteria:

  • breast cancer with stage III/III (AJCC 7th)
  • occult breast cancer
  • in-situ breast carcinoma
  • bilateral breast cancer
  • male breast cancer
  • breast lymphoma or breast sarcoma
  • combined with Paget's disease
  • received preoperative treatment(including neoadjuvant chemotherapy, endocrine therapy and target therapy
  • positive surgical margin
  • axillary lymph nodes dissection or sentinel lymph node biopsy omitted
  • regional lymph nodes radiation needed
  • boost volume larger than 1/4 of the whole breast
  • tumor bed unable to recognize on CT
  • prior invasive malignant tumor history
  • prior radiation to thoracic
  • connective tissue disease, such as active systemic lupus erythematosus and scleroderma, etc.

  • severe, active co-morbidity, defined as follows:

    • unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • severe, acute bacterial or fungal infection within the last 2 weeks
    • chronic obstructive pulmonary disease exacerbation or other respiratory illness within 30 days
  • pregnant women

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: SIB group

Radiation therapy:

daily 5 days per week for 3 weeks. 43.5 Gy in 15 fractions to the whole breast 49.5 Gy in 15 fractions to the tumor bed boost
Stråling: Radiation therapy

Radiation to the whole breast: 43.5 Gy in 15 fractions in 3 weeks. Simultaneous radiation to the surgical cavity: 49.5 Gy in 15 fractions in 3 weeks.

Intensity modulated radiation treatment is used.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
acute radiation induced dermatitis by CTCAE within 3 months
Tidsramme: 3 months
radiation induced skin toxicity, including rash, dry skin, ulceration etc., occurring immediately after radiation.
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation
Tidsramme: 3 months to 1 year
any radiation induced toxicity occurring after the radiation
3 months to 1 year
breast cosmetic result as measured by Harvard scale of breast cosmesis (excellent, good, fair, poor) every 3 months for 1year
Tidsramme: every 3 months for 1year
breast cosmetic evaluation after breast conserving surgery and radiation, using Harvard scale.
every 3 months for 1year
quality of life as measured by Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) every 3 months for 1 year
Tidsramme: every 3 months for 1 year
Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) is used to evaluated the quality of life: all scale range: 0-144; sub-scale range: physical well being: 0-28; social well being: 0-28; emotional well being 0-24; functional well being 0-28; additional consideration: 0-36; the higher the better
every 3 months for 1 year
quality of life as measured by Breast Cancer Treatment Outcome Scale(BCTOS) every 3 months for 1 year
Tidsramme: every 3 months for 1 year
Functional Assessment of Breast Cancer Treatment Outcome Scale(BCTOS) is used to evaluated the quality of life. the range of BCTOS is 22-88, the smaller the better
every 3 months for 1 year
in-breast recurrence rate at 1 year of radiation completion
Tidsramme: 1 year
recurrence occurred in the treated breast.
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Efterforskere

  • Ledende efterforsker: Yexiong Li, Professor, Cancer Hospital/Institution, Chinese Academic Medical Sciences and Peking Union Medical College

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 (Faktiske)

1. januar 2017

Primær færdiggørelse (Faktiske)

1. januar 2019

Studieafslutning (Faktiske)

1. januar 2019

Datoer for studieregistrering

Først indsendt

25. juli 2017

Først indsendt, der opfyldte QC-kriterier

23. oktober 2017

Først opslået (Faktiske)

25. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCC2016YQ-19

Plan for individuelle deltagerdata (IPD)

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