The RACC trial –Robot-assisted Approach to Cervical Cancer
Research type
Research Study
Full title
A multi-centre open-label randomised non-inferiority trial of robot assisted laparoscopic surgery versus laparotomy in women with early stage cervical cancer
IRAS ID
304398
Contact name
Jeremy Twigg
Contact email
Sponsor organisation
Karolinska University Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Cervical cancer is the fourth commonest cause of cancer-related death among women worldwide, with around 500,000 new cases a year. Fewer women in the industrialised world are affected and mortality is also lower there. Around 1400 women a year develop this disease in the Nordic region and the total 5-year survival rate is 58-67%. In Sweden around 550 women a year succumb, with a median age of 48 years. Furthermore, half of them develop symptoms at an early stage, when the disease can be treated surgically and 5-year survival is good (>90%).
The surgical treatment of cervical cancer consists of a procedure known as radical hysterectomy, where the uterus, cervix, its supporting tissue and also the upper vagina are removed, together with pelvic lymph nodes. This has traditionally been performed by open surgery; in other words an incision is made in the abdomen to gain surgical access. Since the 1990s, however, keyhole surgery has become increasingly common in the treatment of cervical cancer and almost standard practice in many parts of the world. Robotic surgery, which is an advanced form of traditional keyhole surgery, has over the past 15 years or so become an established method of advanced pelvic surgery, including operations for cervical cancer. In Sweden and the other Nordic countries, the majority of patients with early cervical cancer nowadays undergo robotic surgery.
Previous observational studies have shown that the way in which access is obtained to the abdominal cavity (keyhole technique or open surgery) makes no difference to the oncological outcome (survival and disease recurrence), but that keyhole surgery does have advantages in the form of shorter hospital stays, less bleeding and complications, plus faster post-surgical recovery.
In 2018, however, results were published from an international comparative study started in 2007, which investigated differences in disease recurrence following surgery for cervical cancer depending on whether traditional keyhole surgery or open surgery was used (the LACC study) (1). Contrary to expectations, the results showed that women who underwent keyhole surgery had a higher risk of
recurrence (after a median follow up of 30 months). All of the relapses were concentrated in 13 of the >30 participating centres. Thus the LACC study evaluated traditional keyhole surgery and not robotic surgery. Unpublished data from Swedish (and Danish) quality registries in which the majority of patients undergo robotic surgery do not show this difference (after a median follow up of 44 months).
There are, at present, no randomised trials comparing robotic surgery and open surgery with recurrence and survival as the primary outcome measure for the majority of diagnoses in which robotic surgery is used (and is, moreover, already an established method).
As robotic surgery has established itself as the surgical technique of choice in the Nordic region for surgical treatment of early cervical cancer, it is extremely important that we should now, without delay, assess its oncological safety, so that women receive the surgical technique that is safest.1. Ramirez PT, Frumovitz M, Pareja R, et al. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. The New England Journal of Medicine 2018; 379(20): 1895-904.
REC name
London - Surrey Research Ethics Committee
REC reference
22/LO/0589
Date of REC Opinion
18 Oct 2022
REC opinion
Further Information Favourable Opinion