Titre officiel
Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection
Sommaire:
Bien que les récidives du cancer du sein
dans la paroi thoracique soient rares, elles représentent un scénario clinique
difficile. Le rôle de la résection de l’épaisseur entière de la paroi
thoracique (REEPT) pour les récidives du cancer du sein dans la paroi
thoracique est à la fois controversé et compliqué par le fait qu’il n’existe
pas de données prospectives évaluant l’utilité de la REEPT pour le
prolongement de la survie ou l’amélioration de la qualité de vie liée à la
santé (QdVLS); les données probantes permettant de guider les décisions
thérapeutiques sont donc insuffisantes. La collecte prospective de données sur
la QdVLS, les récidives loco-régionales (RLR) et la survie est donc
essentielle chez cette population. Par conséquent, nous avons conçu un essai
prospectif visant à évaluer les résultats liés à la REEPT sur le plan
des RLR et de la QdVLS ainsi que de la morbidité et de la mortalité à
court terme, en portant également attention (mesure secondaire) aux bienfaits
sur la survie globale à long terme.
Description de l'essai
Primary Outcome:
- differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores
Secondary Outcome:
- FACT-B scale
- Local Recurrence
- Morbidity and mortality
- Overall Survival
- Disease Free Survival
- Brief Pain Inventory
This study is a prospective, non-randomized cohort study for
patients with chest wall-recurrent/invasive breast cancer treated with full
thickness chest wall resection (FTCWR), chemotherapy and/or radiation. The design
of this study was created using the framework for surgical trials set out by
the IDEAL collaboration (Idea, Development, Exploration, Assessment, Long-Term
follow up), 14 after a systematic evaluation of the current literature had been
completed. Given that no prospective evidence exists in this patient population
and based on the IDEAL framework, this study is designed to create a
prospective registry.
Data on the efficacy of the standard interventions (surgery,
chemotherapy, radiation) will be evaluated using 'global criteria', that is,
the data that will be collected via the scores on the FACT-B, the Brief Pain
Inventory, and the specific cancer outcomes as outlined previously (local
regional recurrence (LRC), overall survival, short term morbidity and mortality
as well as disease-free survival).
The primary objective is to measure the differences in
Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores from
baseline to 6 month evaluation.
In addition to measuring health related quality of life
(HRQOL) at 6 months, differences in the FACT-B scale at 1-month, 3-months and
1-year postoperatively will be examined. Rates of LRC, defined as local
recurrence in the ipsilateral chest wall, axilla, infra- or supraclavicular
region at 1, 2, 3 and 5-years postoperatively will be measured, as well as
thirty and ninety-day morbidity and mortality (to be classified using the
Thoracic Morbidity and Mortality (TM and M) classification system). As well,
data will be collected on overall survival, measured as the proportion of
patients surviving to at 1-year, 2-years, 3-years and 5 years postoperatively.
Lastly, data will be collected on disease-free survival, defined as any
evidence of systemic recurrence plus LRR at 1-year, 2-years, 3-years and 5-years
postoperatively.
Voir cet essai sur ClinicalTrials.gov
