EORTC TOLERANCE clinical trial: addressing a rare cancer in elderly patients
The EORTC has an important track record in the development and use of Quality of Life (QoL) measurement instruments in clinical trials. Studies usually focus on radiological and survival endpoints with QoL as a supplementary endpoint, but for older patients it is known that QoL rather than length of life is increasingly important. Evidence on optimal treatments in the elderly with metastatic soft tissue sarcoma is limited, yet patients understandably want to have relevant information before taking the decision to start palliative treatment.
TOLERANCE presentation at ESMO 2022
The EORTC TOLERANCE, an academic clinical trial for this specific group of metastatic elderly rare cancer patients has been designed with significant input from patients. The study design was recently presented by Professor Winette van der Graaf, EORTC President and study coordinator at the 2022 European Society of Medical Oncology (ESMO) Congress in September in Paris, France.
The sarcoma clinical trial
In the randomised three-arm study the primary objective is QoL, particularly self-reported physical and role functioning at 12 weeks. In the trial, standard three-weekly doxorubicin treatment will be compared to metronomic (frequent administration of low dose) schedules of doxorubicin or cyclophosphamide. Patients older than 70, or between 65 and 69 years of age with a G8 score of 14 or less with progressive metastatic soft tissue sarcoma will be enrolled in the study. A total of 185 patients is needed to get an answer as to whether metronomic doxorubicin or cyclophosphamide leads to a lower burden in terms of physical and role functioning than the standard doxorubicin schedule.
Rare cancer in elderly patients
The EORTC TOLERANCE trial is of significant relevance for the aging population of this rare cancer, and therefore of substantial importance for the Rising Tide Foundation for Clinical Cancer Research.
RTFCCR`s mission is to support clinical trials designed with patients at their centre and aiming at changing the standard of care to reduce disease burden and ameliorate patients’ lives. For this reason, RTFCCR is proudly supporting the TOLERANCE study.
TOLERANCE is currently open for patient recruitment in Jordan and Cyprus while opening of centres in Denmark, Germany, Italy, The Netherlands, Spain and the UK are to follow until December 2022.
About the Rising Tide Foundation for Clinical Cancer Research
Rising Tide Foundation for Clinical Cancer Research (RTFCCR) is a charitable, non-profit organization established in 2010 and located in Schaffhausen Switzerland. RTFCCR’s primary consideration in granting support is given to truly innovative, unique, patient-centered clinical research. The long-term ambition of the foundation is to optimize partnerships and attract the best in Phase I to Phase III clinical trials that aim to bring maximum patient benefit in the shortest time possible. With patients at the core of the mission, the foundation strives to support clinical trials resulting in the creation of less toxic therapeutic approaches, better disease burden management, earlier cancer detection, and innovative intervention strategies that will lead to increased quality of life and survival.
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