Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma. A multicentre observational study.

Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22671

Enrollment

150

Registered

2020-03-19

Start date

2020-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vulva cancer

Interventions

Sentinel node procedure

Eligibility

Inclusion criteria

Inclusion criteria: - 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 10 mm sort axis) or suspicious nodes. - Fit for surgery

Exclusion criteria

Exclusion criteria: A 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 outcomes

Primary

Measure	Time frame
To investigate the safety of replacing complete IFL by SLN procedure in women with a first recurrent vulvar SCC in tumours < 4 cm.	—

Secondary

Measure	Time frame
1) To investigate the feasibility of the SLN procedure in patients with a first recurrence of vulvar SCC. (Success rate of the SLN procedure, surgical drawbacks) 2) To evaluate the short and long-term morbidity associated with the sentinel lymph node procedure in patients with a first recurrence of vulvar SCC.(complications, wound healing problems, long term sequela, quality of life) 3) To evaluate the short and long-term morbidity associated with treatment of a first recurrence of vulvar SCC.(complications, wound healing problems, long term sequela, quality of life)	—

Measure

Time frame

1) To investigate the feasibility of the SLN procedure in patients with a first recurrence of vulvar SCC. (Success rate of the SLN procedure, surgical drawbacks) 2) To evaluate the short and long-term morbidity associated with the sentinel lymph node procedure in patients with a first recurrence of vulvar SCC.(complications, wound healing problems, long term sequela, quality of life) 3) To evaluate the short and long-term morbidity associated with treatment of a first recurrence of vulvar SCC.(complications, wound healing problems, long term sequela, quality of life)

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Contacts

Public ContactLena van Doorn

ErasmusMC Cancer Institute

h.vandoorn@erasmusmc.nl+31630778464

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)