- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01537406
Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy (BIMRT)
Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to "To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique".
The investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8R6V5
- BCCA - Vancouver Island Cancer Centre
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study
Exclusion Criteria:
- Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Tilbagevirkende kraft
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy.
Tidsramme: 8 years post RT
|
A Self pain measurement questionnaire using Visual analog scale (VAS) The nurse coordinator will assess the subject's breast pain due to radiation using the CTCAE 4.0 scale Subjects will complete a Self pain measurement short form of the McGill pain questionnaire
|
8 years post RT
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Does breast IMRT reduce the occurrence of late radiation therapy side effects
Tidsramme: 8 years post RT
|
A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts. Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire |
8 years post RT
|
Does breast IMRT effect long term QOL
Tidsramme: 8 Years post RT
|
A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts. Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire |
8 Years post RT
|
Does IMRT effect local recurrence rates, overall and disease free survivals.
Tidsramme: 8 years post RT
|
Data collection of local recurrences, overall and disease free survivals.
|
8 years post RT
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jean-Philippe Pignol, MD, Odette Cancer Centre
- Ledende efterforsker: Pauline Truong, MD, BCCA - Vancouver Island Cancer Centre
- Ledende efterforsker: Ivo Olivotto, MD, BCCA - Vancouver Island Cancer Centre
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- BCCABreastIMRT
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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