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

Completed

• Conditions: Vulvar cancer; Cancer

• Registration Number: ISRCTN37773303
• Lead Sponsor: niversity Medical Center Groningen (UMCG) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. T1, T2 (<4 cm) primary squamous cell carcinoma of the vulva
2. Depth of invasion >1 mm
3. Not encroaching in urethra, vagina or anus with clinically negative inguinofemoral lymph nodes
4. Preoperative imaging does not show enlarged (<1.5 cm) or suspicious nodes
5. Informed consent

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Groin recurrences

Secondary Outcome Measures

Name	Time	Method
Treatment-associated morbidity