1. To study the safety and feasibility of para-aortic surgical staging in advanced cervical cancer in the Netherlands.2. To provide insight in the possible effectiveness of para-aortic surgical staging in advanced cervical cancer as compared to…
ID
Source
Brief title
Condition
- Metastases
- Cervix disorders (excl infections and inflammations)
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the safety and feasibility of para-aortic surgical
staging. This will be assessed by registering proportion of included patients
amongst all eligible patients. Furthermore by registering duration of surgical
procedure, blood loss, complications and adverse events.
Nodal yield will be compared to results found in other studies in order to
assess completeness of lymphadenectomy.
Secondary outcome
Data on sensitivity, specificity, negative and positive predictive value of
MRI, PET-CT and surgical staging will be gathered to base power calculations
for a future independent phase 3 trial.
The amount and diameter of metastases and proportion of modified initial
treatment plans for adjuvant therapy, due to histological findings will be
documented.
Morbidity and mortality, Quality of life (QLQ-C30 version 3.0, QLQ-CX24) and
progression-free and overall survival during the first year after surgery will
be compared between treatment arms. Treatment delay due to surgical
intervention and histological analyses will be compared. Time to treatment will
be measured from the day of randomization until start of chemo radiation.
Background summary
In the Netherlands, surgical staging of para-aortic lymph nodes in advanced
cervical cancer is not common practice. This study will assess safety and
feasibility of surgical staging in advanced cervical cancer in the Netherlands.
It will provide insight in detection rate of micro metastases, and upstaging of
radio therapeutic treatment plan due to surgical staging. This information will
be used to assess the necessity for a Dutch phase 3 study on surgical staging
as well as provide vital information for the power-analysis of this phase 3
study.
Study objective
1. To study the safety and feasibility of para-aortic surgical staging in
advanced cervical cancer in the Netherlands.
2. To provide insight in the possible effectiveness of para-aortic surgical
staging in advanced cervical cancer as compared to current standard of care
with regard to detecting metastases and postoperative morbidity, mortality,
quality of life, (and survival).
Study design
A phase 2 randomized controlled multicenter trial at the Radboudumc, Maastricht
University Medical Center and Gynaecological Oncology Centre South.
Intervention
Para-aortic lymphadenectomy will be added to standard of care and imaging (CT,
MRI and/or Pet-CT) for locally advanced cervical cancer.
Study burden and risks
The intervention group will undergo additional laparotomic, laparoscopic or
robot-assisted trans- or retroperitoneal para-aortic lymphadenectomy.
Intra-operative complications may be bowel, bladder, nerve, and vessel injury.
This may sometimes leadto a conversion to laparotomy. The percentage of
patients with significant morbidity is around 10%, mostly consisting of a post
operative lymphocele, infection and delayed wound healing. However, in
general, the complications of a para-aortal lymphadenectomy do not delay
completion of cervical cancer treatment. Therefore, it is hypothesized that
performing a para-aortal lymphadenectomy before concomitant chemo-radiotherapy
may result in an adjusted treatment plan, leading to better loco-regional
control of the disease and subsequently improves survival and quality of life.
Furthermore the intervention group will undergo standard PET-CT. This might
lead to an additional visit. There is however no additional risk associated
with PET-CT and it can be considered standard of care.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Age * 18 years
Histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix
Stage IB2 , IIA with tumor > 4cm,IIB, IIIA, IIIB, IVA, staging performed as examination under anesthesia (EUA).
WHO-performance 0-2
No evidence of distant metastasis
Fit for surgery
Written informed consent
Exclusion criteria
Previous malignancy (except for non-melanoma skin cancer)
Prior retroperitoneal surgery
Previous pelvic or abdominal radiotherapy
Upper abdominal intraperitoneal disease or evidence of ovarian metastasis
Evidence of distant metastasis on imaging or physical examination
Bulky para-aortic lymph nodes > 2cm
Pregnancy
Otherwise unfit for surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL49310.091.14 |
| OMON | NL-OMON28637 |