Robot-assisted Approach to Cervical Cancer
Robot-assisted Approach to Cervical Cancer
The purpose of the RACC trial is to compare the oncologic outcome defined as recurrence-free
 survival (RFS) between robot-assisted and open radical hysterectomy for the treatment of
 early stage cervical cancer.
BACKGROUND Cervical cancer is one of the most common female malignancies worldwide, with the
 largest proportion of women affected in low income countries. Radical hysterectomy with
 pelvic lymphadenectomy constitutes the primary treatment of early stage cervical cancer.
 Surgery has traditionally been performed by laparotomy but the past 20 years, the use of
 minimally invasive techniques has increased. Several studies suggest that laparoscopic
 radical hysterectomy is associated with less preoperative morbidity and superior quality of
 life.

 In 2005, the Food and Drug Administration (FDA) approved robot-assisted surgery for
 gynaecological indications. Observational studies have confirmed advantages in form of
 shorter hospital stay, less bleeding and acceptable OT. Furthermore, compared to conventional
 laparoscopy OT is significantly shorter with robot technique. Despite wide acceptance and
 implementation of the robotic system into gynecological oncology todate there are mainly
 retrospective observational data published on oncological outcomes, offering a low evidence
 level.

 The sentinel node biopsy concept (SNB) is well established in the surgical management of
 several malignancies including breast, melanoma and vulvar cancer. Theoretically, the
 implementation would change the management of patients with early cervical cancer
 dramatically by avoiding multimodal treatment.

 Traditionally, radiotracers (Technetium) with or without augmentation of blue dye have been
 used for SNB. Novel tracers such as fluorescent dyes (indocyanine green (ICG)) have been
 demonstrated to be superior.

 Apart from detection rate, the rate of bilateral mapping of sentinel nodes and sensitivity
 (false negative rate included), constitutes the most important aspect of the technique. In
 recent ESGO guidelines on the management of stage IA disease SNB is recommended as the
 standard treatment unless in patients with positive LVSI where complete PLND should be
 considered.

 RATIONALE In 2018, the LACC (Laparoscopic Approach to Cervical Cancer) trial was completed
 and the results demonstrated inferiority for minimally invasive surgery (MIS). In the trial,
 631 women were randomized to MIS (85% by traditional laparoscopy and the remaining by
 robot-assisted surgery). Disease-free and overall survival were significantly worse by MIS
 with no observed advantage in quality of life or perioperative morbidity.

 After the trial was closed, two large population-based studies from the Nordic countries
 (unpublished data) show no difference in either DFS or OS. The absolute majority in these
 studies were operated by robot-assisted surgery.

 Robot-assisted surgery has replaced traditional laparoscopy for radical hysterectomy. Whether
 robot-assisted surgery is associated with better oncologic outcomes than traditional
 laparoscopy is unknown.The purpose of the RACC trial is to assess the safety of
 robot-assisted laparoscopy for the surgical treatment of early stage cervical cancer.

 RATIONALE FOR THE QUALITY OF LIFE ASSESSMENT Two randomised controlled trials (LAP2 and LACE)
 have demonstrated that MIS is superior to laparotomy i in terms of perioperative morbidity
 and quality of life. However, the LACC trial did not show any differences between MIS and
 laparotomy for these outcomes. Whether robot-assisted surgery offers superior outcomes is
 unknown. In the RACC trial, QoL will be assessed in both arms at 5 time points using the
 EORTC QLQ-CX24 form and the FSFI (Female Sexual Function Index).

 RATIONALE FOR THE SENTINEL NODE ALGORITHM Tumor extension to pelvic lymph nodes is the most
 important prognostic factor in early stage cervical cancer. Traditionally, nodal assessment
 has been performed through systematic pelvic lymphadenectomy. Sentinel node concepts have
 been evaluated in several smaller studies but none with sufficient power to properly assess
 the diagnostic accuracy.

 PRIMARY ENDPOINT

 - Recurrence-free survival (RFS) at 60 months

 SECONDARY ENDPOINTS

 -  Overall survival (OS) at 60 months

 -  Perioperative morbidity

 -  Quality of life

 -  Diagnostic accuracy of a sentinel node algorithm in cervical cancer

 -  Health care costs
Inclusion Criteria:

 -  Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or
 adeno-squamous carcinoma of the uterine cervix;

 -  Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to
 the latest revision of the FIGO staging manual

 -  Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow
 classification)

 -  Patients with adequate bone marrow, renal and hepatic function

 -  ECOG Performance Status of 0, 1 or 2.

 -  Patient must be suitable candidates for surgery.

 -  Patients who have signed an approved Informed Consent

 -  Age 18 years or older

 Exclusion Criteria:

 -  Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous
 carcinoma of the uterine cervix

 -  Tumor size greater than 4 cm

 -  FIGO stage II-IV (except IIA1)

 -  Patients with a history of pelvic or abdominal radiotherapy

 -  Patients who are pregnant

 -  Patients with contraindications to surgery

 -  Patients with evidence of metastatic disease by conventional imaging, enlarged pelvic
 or aortic lymph nodes > 2cm; or histologically positive lymph nodes

 -  Serious concomitant systemic disorders incompatible with the study (at the discretion
 of the investigator)

 -  Patients unable to withstand prolonged lithotomy and steep Trendelenburg position

 -  Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma
 skin cancer, breast cancer T1N0M0 grade 1 or 2 without any signs of recurrence or
 activity)