We aim to demonstrate that robot-assisted laparoscopic radical hysterectomy is non-inferior to conventional laparotomy in recurrence free survival of patients with early stage cervical cancer (stage 1B1, 1B2 and 2A1).
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Cervix disorders (excl infections and inflammations)
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We expect to include 200 patients during the 3-year recruitment phase. In these
patients, we expect a recurrence free survival of 88% with no difference
between the laparotomy and robot assisted groups based on the Dutch cervical
cancer treatment analysis.
For the international study population, as mentioned in the protocol the RFS
is 85% The hypothesis is that there is no difference between the two groups
with a non inferiority threshold of 7.5% In summary: With a recurrence free
survival of 85%, with a power of 80% and an alpha of 5%, a difference of> 7.5%
can be excluded.
Secondary outcome
• Overall survival
• Health related quality of life including lymphoedema, bladder and sexual
dysfunction
• Intraoperative complications
• Postoperative complications
• Diagnostic accuracy of the pelvic sentinel lymph node concept
Secondary outcomes are expected to be a shorter hospital stay and less
complications reflected in better QoL scores for the RALS-treated group.
Background summary
Cervical cancer is a relatively rare tumour with little under 700 new cases
each year in the Netherlands. Roughly half of those patients are considered
operable and have a good prognosis with a disease free 5-year survival of
85-98% depending on among other things, histology and operative radicality .
The standard treatment for these patients is surgical removal of the uterus
(radical hysterectomy) (including parametrial resection with ureteric and
bladder mobilization and a pelvic lymphadenectomy). This type of surgery is
associated with complication risks and increased morbidity including slower
postoperative recovery, voiding problems and swelling (lymphedema). Reduction
of morbidity and improvement of recovery have been the main focus to improve
patient care, while concurrently maintaining good oncological outcome.
Robot assisted laparoscopic surgery (RALS) has strongly improved the standard
of care with the advantage of shorter hospital stay and less postoperative
complications.in several Dutch cancer centres, including Erasmus MC UMCU,
Radboud MC and MUMC. Data from the Dutch cancer registration (supplemented with
an extensive treatment dataset) shows there is no difference in survival or
recurrence between surgical methods (open conventional surgery or RALS).
However, results from an international randomized trial (LACC-trail) that
compared mainly conventional (not robot assisted) laparoscopic surgery and
laparotomic surgery (initiated 2007) shows that patients subjected to
conventional laparoscopic surgery had an increased risk of recurrence. This
difference was not observed in, among other analysis, Sweden, Denmark or the
Netherlands with robot-assisted laparoscopic surgery. This has caused an
intense debate, whether the results from the LACC trial represents all of the
western world and Europe in specific. Therefore, the multi-centre RACC trial
was initiated by the Karolinska Hospital Stockholm
In this project, we will perform a randomized trial to establish the
oncological safety of current minimally invasive practice (RALS) in the
Netherlands.
Study objective
We aim to demonstrate that robot-assisted laparoscopic radical hysterectomy is
non-inferior to conventional laparotomy in recurrence free survival of patients
with early stage cervical cancer (stage 1B1, 1B2 and 2A1).
Study design
Randomised controlled non-inferiority trial.
We will randomize women diagnosed with squamous cell or adeno carcinoma of the
cervix indicated for radical hysterectomy 1:1 to either robot assisted or
laparotomic surgery. Quality of life (QoL) analyses will be performed with
questionnaires. After standard 5-year follow-up, we will compare recurrence
free survival , quality of life measurements, as well as cost-effectiveness
(average length of hospitalization and complications)
This project proposal entails the Dutch multi-centre participation of the RACC
trial (RACC-trial the Netherlands)
Intervention
Robot-assisted laparoscopic radical hysterectomy and pelvic lymphadenctomy
versus radical hysterectomy and pelvic lymphadenectomy by laparotomy
Study burden and risks
There is no additional risk and minimal burden associated with trial
participation since both treatments are standard clinical practice. The
additional burden consists of the time spend to fill out the questionnaires
Eugeniavägen 3
Solna, Stockholm 171 76
SE
Eugeniavägen 3
Solna, Stockholm 171 76
SE
Listed location countries
Age
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. It is at the discretion of local principal investigators to decide if
tumours fulfilling the SHAPE-criteria should be considered an exclusion
criterion (pending revisions of national and international guideline
recommendations).
• 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). It is at the discretion of local principal
investigators to decide if tumours fulfilling the SHAPE-criteria should be
considered an exclusion criterion (pending revisions of national and
international guideline recommendations).
• 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03719547 |
| CCMO | NL72104.078.20 |