The RACC trial -Robot-assisted Approach to Cervical Cancer. A multi-centre open-label randomised non-inferiority trial of robotassisted laparoscopic surgery versus laparotomy in women with early stage cervical cancer.

Recruiting

Conditions: cervical cancer
cervical carcinoma
10038594
10013364
10029903

Registration Number: NL-OMON49363

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

• Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or
adenosquamous
carcinoma of the uterine cervix;
• Women with histologically confirmed FIGO stage IB (IB3 excluded) and IIA1
disease
• Women undergoing either a Type B or C radical hysterectomy according to
Querleu
Morrow classification
• ECOG Performance Status of 0, 1 or 2
• Patient must be suitable for surgery.
• Patients who have signed an approved Informed Consent
• Age> 18 years

Exclusion Criteria

• Any histology other than adenocarcinoma, squamous cell carcinoma or
adeno-squamous
carcinoma of the uterine cervix
• Tumor size greater than 4 cm, estimated by either magnetic resonance imaging
(MRI) or
clinical examination
• FIGO stage II-IV (except IIA1)
• Women with a history of pelvic or abdominal radiotherapy
• Women who are pregnant
• Women with contraindications to surgery
• Women with evidence of metastatic disease by conventional imaging studies,
enlarged
pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
• Serious concomitant systemic disorders incompatible with surgery or study (at
the
discretion of the investigator)
• Women unable to withstand prolonged lithotomy and steep Trendelenburg position
• Women with secondary invasive neoplasm in the last 5 years (except
non-melanoma
skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of
recurrence or
activity)
• Women with iodine allergy cannot be part of the sentinel node part of the
trial but are
allowed randomisation as to the primary outcome

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We expect to include 200 patients during the 3-year recruitment phase. In these<br /><br>patients, we expect a recurrence free survival of 88% with no difference<br /><br>between the laparotomy and robot assisted groups based on the Dutch cervical<br /><br>cancer treatment analysis.<br /><br>For the international study population, as mentioned in the protocol the RFS<br /><br>is 85% The hypothesis is that there is no difference between the two groups<br /><br>with a non inferiority threshold of 7.5% In summary: With a recurrence free<br /><br>survival of 85%, with a power of 80% and an alpha of 5%, a difference of> 7.5%<br /><br>can be excluded.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Overall survival<br /><br>• Health related quality of life including lymphoedema, bladder and sexual<br /><br>dysfunction<br /><br>• Intraoperative complications<br /><br>• Postoperative complications<br /><br>• Diagnostic accuracy of the pelvic sentinel lymph node concept<br /><br><br /><br>Secondary outcomes are expected to be a shorter hospital stay and less<br /><br>complications reflected in better QoL scores for the RALS-treated group.</p><br>