* TOLERANCE (EORTC 1976-STBSG-QLG-ETF)
Research type
Research Study
Full title
TOLERANCE: a 3 arm randomized study on healTh-related quality Of Life of EldeRly pAtients with advaNced soft tissue sarComa undergoing doxorubicin every three weeks or doxorubicin weekly or cyclophosphamide plus predniso(lo)ne treatment
IRAS ID
1004712
Contact name
Sarah Pratap
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2021-000125-27
Clinicaltrials.gov Identifier
Research summary
This study is for elderly adults who have been diagnosed with a soft tissue sarcoma that has spread and cannot be removed by surgery. The standard treatment given is palliative chemotherapy. It is called doxorubicin and is given every three weeks at hospital.
In this study we will compare the standard chemotherapy (doxorubicin) with two alternative chemotherapy options (doxorubicin at a lower dose or cyclophosphamide and predniso(lo)ne). This has been studied in patients with other types of cancer and has shown to be active against the tumour and there are fewer, more tolerated side effects compared with the standard palliative chemotherapy. This means that people are more likely to be able to perform their daily activities and have a better quality of life.
Research has already shown that some tumours (mainly breast and prostate), that are controlled well by standard palliative chemotherapy, may respond well to these different treatment regimens. Many elderly people with sarcoma have to stop palliative chemotherapy due to side effects, so this study is an opportunity to investigate other treatment options. Reducing the doxirubicin dose or giving low-dose and frequent administration of cyclophosphamide and predniso(lo)ne without drug-free breaks may be an alternative to the traditional regimen. It has already proven to be advantageous for selected patients which is why this study is being done.
We will look at the safety and tolerability of these different treatment regimens and the effect on the participants’ health and quality of life. In this study the benefit is also measured by the length of time that participants live with the disease without it getting worse (Progression Free Survival).
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0133
Date of REC Opinion
3 Nov 2022
REC opinion
Further Information Favourable Opinion