GROningen INternational Study on Sentinel nodes in Vulvar cancer. An observational study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23376

Enrollment

1500

Registered

2006-01-18

Start date

2005-12-01

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

Squamous cell carcinoma of the vulva

Interventions

Radiotherapy instead of inguinofemoral lymphadenectomy in patients with SN metastasis

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primary squamous cell carcinoma of the vulva 1mm; 3. Not encroaching in urethra, vagina or anus, and clinically negative inguinofemoral lymph nodes; 4. Preoperative imaging does not show enlarged (< 1.5 cm) / suspicious nodes; 5. Possibility to obtain informed consent.

Exclusion criteria

Exclusion criteria: 1. Inoperable tumors and tumors with diameter > 4cm; 2. Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (>1.5 cm) / suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases; 3. Patients with multifocal tumors.

Design outcomes

Primary

Measure	Time frame
Groin recurrence rate	—

Secondary

Measure	Time frame
Treatment associated morbidity.	—

Contacts

Public ContactMaaike Oonk

University Medical Center Groningen

m.h.m.oonk@umcg.nl0631623213

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)