STRASS 2 (1809-STBSG)
Research type
Research Study
Full title
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma
IRAS ID
285701
Contact name
Dirk Strauss
Contact email
Sponsor organisation
European Organisation for the Research and Treatment of Cancer (EORTC)
Eudract number
2019-003543-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 3 months, 1 days
Research summary
This study is for adults who have a retroperitoneal sarcoma that has not spread to other parts of the body and can be treated by surgery.
The purpose of this study is to find out whether giving chemotherapy before surgery is a better treatment compared to surgery alone. This will be measured by the length of time that the participant lives without the disease returning (disease free survival. At this stage of the disease, the participant would usually only have surgery. We will also investigate whether it is safe to have chemotherapy before surgery.
Doctors think that giving chemotherapy before undergoing surgery may improve the outcome of this type of cancer but there is no proof of this yet, which is why this study is being done.
The study will evaluate the effects of surgery with or without chemotherapy using clinical examinations, regular scans and blood tests. The study has an optional translational research component where tumour samples will be collected. These samples will be analysed to learn more about this disease.
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
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0301
Date of REC Opinion
16 Dec 2020
REC opinion
Further Information Favourable Opinion