EORTC 1447
Research type
Research Study
Full title
Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma.
IRAS ID
229325
Contact name
Robin Jones
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2016-003535-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
This study is for adults who have advanced or metastatic soft tissue sarcoma who have benefited from receiving chemotherapy (doxorubicin). At this point in the disease standard practice is for these patients to receive no treatment (observation) until their cancer starts growing again. This study is looking at giving some patients a drug called trabectedin instead of no treatment. The purpose of the study is to find out whether giving the drug trabectedin is better at working against the disease than no treatment. This is measured by the length of time that participants live with the disease before it gets worse (progression-free survival).
The prognosis for this group of people is poor. There is a need to investigate new treatment options for people at this stage of their disease. Several new drugs have been investigated and trabectedin has shown to be one of the more active drugs with no cumulative toxicity and prolonged treatment has proven to be feasible.
The study will compare the effects of trabectedin with observation using clinical examinations, regular scans and blood tests. Tumour samples and blood tests will also be used to understand the effects of the drug.
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 a non-profit organisation called the EORTC (European Organisation for Research and Treatment of Cancer), based in Brussels.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/1923
Date of REC Opinion
11 Dec 2017
REC opinion
Further Information Favourable Opinion