The primary objective is to investigate the safety of replacing complete IFL by the SLN procedure in patients with local recurrent vulvar squamous cell carcinoma without suspicious groin lymph nodes.
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Vulvovaginal disorders (excl infections and inflammations)
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end point is the number of groin recurrences after SLN procedure.
Secondary outcome
Success rate of the SLN procedure, surgical drawbacks, wound healing problems,
long term sequela, and quality of life in women treated for a 1st recurrent
vulvar cancer.
Background summary
Standard groin treatment in recurrent vulvar cancer consists of an uni or
bilateral inguinal lymph node dissection (IFL), whereas in the primary setting
a sentinel lymph node (SLN) procedure is performed in case of unifocal tumours
< 4cm without suspicious groin lymph nodes at imaging. The advantages of SLN
procedure over an IFL are obvious: the short and long term sequels such as
wound healing problems, lymph cyst formation, recurrent erysipelas and lymph
oedema are much less common after SLN procedure. In a national retrospective
analysis we showed that SLN is feasible in selected recurrent vulvar cancer
patients. This national prospective observational study aims to investigate the
safety of such procedure. Since little is known on the outcome of 1st recurrent
vulvar cancer we also gather more information on women with a first recurrence,
not eligible for the SLN procedure.
Study objective
The primary objective is to investigate the safety of replacing complete IFL by
the SLN procedure in patients with local recurrent vulvar squamous cell
carcinoma without suspicious groin lymph nodes.
Study design
This is predominantly a prospective multicentre observational study on sentinel
lymph node (SLN) procedure in women with local recurrent vulvar cancer. Besides
it is an observational study on the treatment and outcome of women with a local
recurrent vulvar cancer, not eligible for the SLN procedure.
Study burden and risks
In this study, similar to the current routine, preoperative imaging of chest,
abdomen and groins is performed. The patient is informed about the standard
procedure and about the option of a SLN procedure. She and her treating
gynaecologist decide on the preferred treatment. Prior to surgery the planned
surgical procedure is recorded, including patients* consent for IFL in case the
SLN procedure fails. The surgical procedure (SLN procedure) will be less
extensive compared to routine IFL, with less unfavourable short and long term
effects, such as infections and lymph oedema. In case of groin metastases
detected in the SLN procedure further treatment is warranted, either by surgery
(uni or bilateral IFL) and/or by radiotherapy. At follow up participants will
undergo (non-invasive) ultrasonography studies of the groin at 6 and 12 months.
Participants will be asked to fill in additional questionnaires at baseline, 6
and 12 months. In case of a groin recurrence (due to failed SLN procedure)
further treatment is warranted, probably resulting in a poorer prognosis with a
high mortality rate (probably 80-90%). Currently, robust data on the occurrence
of groin recurrence after either SLN biopsy or IFL for recurrent vulvar cancer
is lacking. Given the lower morbidity and less short and long term side effects
of the SLN procedure compared to IFL an additional 5% failure rate is
considered acceptable.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible for the study (non SLN cohort and SLN cohort, group
A-C): - Possible to understand and read Dutch. - Possible to understand the
study and give informed consent. - No age limit specified. - Patients should
mentally, physically and geographically be able to undergo follow-up. In order
to be eligible to undergo the SLN procedure, a subject must meet all of the
following criteria: - First local recurrent SCC of the vulva. - Previous
treatment with wide local excision or (partial) vulvectomy tumours < 4 cm., not
encroaching in urethra, vagina or anus with clinically negative inguinofemoral
lymph nodes. - Localisation and size of the tumour are such that perilesional
injection of the tracers at three or four sites is possible. - Preoperative
imaging does not show enlarged (> 10 mm sort axis) or suspicious nodes. - Fit
for surgery
Exclusion criteria
Potential subject who meets any of the following criteria should not undergo
the SLN procedure in the study arm (A-B), the patient can be asked for the non
SLN cohort. - Inoperable tumours and tumours with diameter > 4 cm. - Patients
with inguinofemoral lymph nodes at palpation clinically suspect for metastases,
at radiology enlarged (> 10 mm short axis) / suspicious groin nodes and with
cytological proven inguinofemoral lymph node metastases. - A history of
bilateral IFL and radiotherapy to the groins. - A lateral tumour and history of
ipsilateral IFL and ipsilateral radiotherapy. - Tumour encroaching urethra,
vagina, or anus. - Previous surgery of the vulva was not radical (margin < 1
mm) and additional treatment (2nd surgery or radiotherapy) was not performed. -
Multifocal recurrent disease of the vulva. - Synchronous, non- curable 2nd
malignancy.
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 |
|---|---|
| CCMO | NL70149.078.19 |