Image guided radiotherapy and adaptive brachytherapy for cervix cancer
Research type
Research Study
Full title
Image guided intensity modulated external beam radiochemotherapy and MRI based adaptive brachytherapy in locally advanced cervical cancer (EMBRACE-II)
IRAS ID
201374
Contact name
Deborah L Gregory
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
5 years, 9 months, 2 days
Research summary
The study originates in and is coordinated by a European centre. The purpose of this application is to allow UK centres to participate. Cervix cancer is a relatively rare cancer and research in the past has been largely limited to single institution case series. Recently a European collaborative group endorsed by GEC-ESTRO has collected prospective data regarding current management strategy and outcomes to report the current standard of care and outcomes in Europe. This is a single arm interventional study following from the previous work. It is for women with cervix cancers too advanced to be treated surgically. Until recently standard treatment was (conformal) external beam radiotherapy given with concurrent chemotherapy followed by brachytherapy delivered with intrauterine applicators. Studies have shown that this is an effective treatment in small and medium sized tumours but disease control in larger tumours is suboptimal resulting in uncontrolled pelvic tumour in 25% of patients with very locally advanced tumours (stage3b). Treatment using conventional conformal radiotherapy and traditional brachytherapy confers significant long term toxicity (up to 30% experience moderate to severe bowel and urinary toxicity), increased patient reported symptoms and reduction in quality of life. Control of larger tumours and treatment toxicity can be improved by using newer techniques. These include image guided brachytherapy with the use of interstitial implants (IGIBT) , dose optimisation and the use of image guided intensity modulated radiotherapy (IGIMRT). This study aims to optimise these strategies across multiple centres by protocolised implementation of IGIMRT, using data from previous collaboration; to reduce volumes irradiated during IGIMRT by risk stratification; and to optimise IGBT dose prescriptions according to data from previous studies. It will be open in a number of centres in mainland Europe and, subject to approval, at least 4-8 in the UK. It aims to recruit 1000 patients over 4 years.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0213
Date of REC Opinion
29 Aug 2017
REC opinion
Further Information Favourable Opinion