Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection

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