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Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy (BIMRT)

7 mars 2012 mis à jour par: British Columbia Cancer Agency

Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy

The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. Also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Cancer du sein

Intervention / Traitement

Radiation: BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

314

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Canada
- British Columbia
  - Victoria, British Columbia, Canada, V8R6V5
    - BCCA - Vancouver Island Cancer Centre
- Ontario
  - Toronto, Ontario, Canada, M4N 3M5
    - Odette Cancer Centre

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Breast cancer subjects treated in Toronto, Ontario, or in Victoria, British Columbia that participated in The Canadian breast IMRT clinical trial between July 2003 to March 2005.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cas uniquement
Perspectives temporelles: Rétrospective

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy. Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Does breast IMRT reduce the occurrence of late radiation therapy side effects Délai: 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 Délai: 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. Délai: 8 years post RT	Data collection of local recurrences, overall and disease free survivals.	8 years post RT

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

British Columbia Cancer Agency

Collaborateurs

Canadian Institutes of Health Research (CIHR)

Les enquêteurs

Chercheur principal: Jean-Philippe Pignol, MD, Odette Cancer Centre
Chercheur principal: Pauline Truong, MD, BCCA - Vancouver Island Cancer Centre
Chercheur principal: Ivo Olivotto, MD, BCCA - Vancouver Island Cancer Centre

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2012

Achèvement primaire (Anticipé)

1 mai 2013

Achèvement de l'étude (Anticipé)