To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the…
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
Recurrence rate at the 24th month of follow-up
Secondary outcome
Prevalence of symptomatic pelvic lymphocele and lower extremity lymphedema, the
two complications that are associated with lymph node staging.
Background summary
Sentinel lymph node (SLN) biopsy is currently used in the management of vulvar
and breast cancers as well as in malignant melanoma. Metastatic involvement of
pelvic lymph nodes is the most important prognostic factor in the early stages
of cervical cancer. SLN biopsy in the management of cervical cancer has been
extensively studied, so a detection technique is well standardized, and a very
low false negative rate in the staging of pelvic lymph nodes has been well
documented. Moreover, SLN evaluation has been reported to improve the accuracy
of lymph node staging due to SLN pathologic ultrastaging, which includes
multiple serial sectioning and immunohistochemical assessment. Despite the
availability of massive data on SLN biopsy in cervical cancer, it is still
rarely used in current clinical management2.
It is the aim of this project to conduct a multicenter prospective
observational trial to confirm a non-inferior oncological outcome and improved
post-operative morbidity after SLN biopsy without following systematic pelvic
lymphadenectomy. The trial has high potential to reach the calculated number of
cases and thus bring in evidence data that will be essential for changing
international guidelines.
Study objective
To evaluate whether a less radical surgical approach with sentinel lymph node
biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.
The null hypothesis is that the recurrence rate after SLN biopsy is
non-inferior to the reference recurrence rate of 7 % (at the 24th month of
follow-up) in patients after systematic pelvic lymphadenectomy, but that the
less radical surgery is associated with significantly lower postoperative
morbidity.
Study design
A multicenter prospective observational trial
Study burden and risks
Abandoning the lymphadenectomy holds the very low risc of leaving behind lymph
nodes with tumor cells.
Na Folimance 2155/15, Vinohrady 2155/15
Praag 2 12000
CZ
Na Folimance 2155/15, Vinohrady 2155/15
Praag 2 12000
CZ
Listed location countries
Age
Inclusion criteria
Cervical cancer
Exclusion criteria
Unable to understand protocol
Design
Recruitment
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 |
|---|---|
| Other | CEEGOG CX-01 , ENGOT-Cx 2 |
| CCMO | NL61162.018.17 |