REDUCE (EORTC 1762-STBSG)
Research type
Research Study
Full title
Reduced dose-density of denosumab for maintenance therapy of unresectable giant cell tumor of bone: a multicenter phase II study "REDUCE"
IRAS ID
261118
Contact name
Palma Dileo
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2018-002096-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 7 months, 31 days
Research summary
This study is for adults who have a giant cell tumour of the bone (GCTB) that cannot be treated by surgery. Participants will already have received almost one year of standard treatment with denosumab which is usually given once every 4 weeks. However, there is a side effect called osteonecrosis of the jaw (bone damage in the jaw) that occurs frequently during or after treatment with denosumab.
In this study, denosumab will be given once every 3 months rather than every 4 weeks. The purpose of this study is to assess the risk and benefits of giving denosumab for more than one year and to investigate whether this modified treatment can reduce side effects without affecting how well denosumab works. This is measured by the length of time that participants live with the disease without it getting worse (Progression Free Survival) and how frequently osteonecrosis of the jaw occurs.
The information from this study will help doctors learn more about the optimal dose of denosumab for patients with giant cell tumour of the bone. This is why this study is being done.
The study will evaluate the effects of denosumab using clinical examinations, regular scans and blood tests. The study has an optional translational research component where tumour and blood samples will be collected. Even though response rates for denosumab treatment in giant cell tumor of the bone are high, no biomarkers are currently known. These samples will be analysed to identify biomarkers of response to denosumab treatment.
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 - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0238
Date of REC Opinion
19 Aug 2019
REC opinion
Further Information Favourable Opinion