Robot-assisted Approach to Cervical Cancer (RACC)

  • STATUS
    Recruiting
  • End date
    Feb 1, 2027
  • participants needed
    800
  • sponsor
    Karolinska Institutet
Updated on 19 April 2022
cancer
hysterectomy
carcinoma
squamous cell carcinoma
lymphadenectomy
adenocarcinoma
diagnostic procedures
cervical carcinoma
cervical disease
cervical cancer stage
iia1

Summary

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.

Description

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

Details
Condition Cervical Cancer
Treatment sentinel lymph node biopsy, Abdominal radical hysterectomy, Robot-assisted radical hysterectomy
Clinical Study IdentifierNCT03719547
SponsorKarolinska Institutet
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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)
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