Grantee Name: Dr. Winette van der Graaf
Project Name: TOLERANCE
Funding Year: 2021
Project period: 4 years
The challenge of treating the fast-growing population of elderly patients with cancer urgently requires adequate treatment, for which guidelines and evidence-based data are lacking. A recent EORTC study, demonstrated that elderly patients with advanced soft tissue sarcomas (a rare type of cancer that starts in tissues like fat or muscle) are underrepresented in clinical trials of first-line chemotherapy. This means that, due to a lack of evidence-based data, there is currently no consensus on the standard of care for the chemotherapeutic treatment of the elderly patients with inoperable or metastatic soft tissue sarcomas. There is therefore an urgent need for development of novel trials for elderly patients that include a health status geriatric screening tool and health-related quality of life (HRQoL) assessments.
The EORTC TOLERANCE is an academic clinical trial comparing different treatments for elderly patients with inoperable or metastatic soft tissue sarcomas in terms of HRQoL. Specifically, it compares metronomic schedules of doxorubicin or cyclophosphamide plus prednisolone versus the standard doxorubicin treatment (3 treatment arms). The ultimate goal of this study is to select the best experimental treatment based on patient self-reported outcomes in order to set a new standard of care in this setting. This aligns with RTF’s mission to support less toxic therapeutic approaches and better disease burden management leading to increased quality of life and survival of cancer patients.
EORTC 1976-STBSG-QLG TOLERANCE is a 3-arm randomised, open label, phase 3 trial coordinated by the EORTC HQ in Brussels. A total number of 185 patients aged from 65 years-old and diagnosed with advanced or metastatic STS will be enrolled over a period of 3.5 years. The trial will open in 31 reference cancer centres in 8 countries (CY, DK, DE, IT, JO, NL, ES, UK).