Groningen International Study on Sentinel nodes in Vulvar cancer - III, a prospective phase II treatment trial

Phase 2

Recruiting

Conditions: vulvar cancer
10038594

Registration Number: NL-OMON53136

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Histological confirmed primary SCC of the vulva
- T1 tumor, not encroaching urethra/vagina/anus
- Depth of invasion > 1mm
- Tumor diameter < 4cm
- Unifocal tumors
- No enlarged (>1.5cm) or suspicious inguinofemoral lymph nodes at imaging
(CT/MRI/ultrasound)
- Possibility to obtain informed consent
- Metastatic sentinel lymph node; size of metastasis > 2mm
- Metastatic sentinel lymph node: more than 1 SN with metastasis <= 2mm
- Adequate bone marrow, renal and liver function:
• Absolute neutrophil count >= 1.5 x 109 /L
• Platelet count >= 100 x 109 /L
• Creatinine clearance >= 40 ml/min measured by the Cockroft Gault
formula
• Total bilirubin < 1.25 x ULN
• Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 x
ULN
- Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group
(ECOG) Scale
- Age 18 years or older
- Life expectancy of >= 12 weeks

Exclusion Criteria

- Inoperable tumors and tumors > 4cm
- Multifocal tumors
- Tumors with other pathology than squamous cell carcinoma
- Patients with enlarged / suspicious lymph nodes which are proven metastatic
after fine needle aspiration cytology
- No other carcinomas, other than basal cell carcinomas, within last 5 years
- History of pelvic radiotherapy
- History of any infection requiring hospitalization or antibiotics within 2
weeks before enrollment
- Pregnant female or nursing mother
- Unstable angina, myocardial infarction, cerebrovascular accident, > Class II
congestive heart failure according to the New York Heart Association
Classification for Congestive Heart Failure within 6 months before enrollment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>- Groin recurrence rate in the first two years after primary treatment </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint:<br /><br>- Treatment related morbidity (CTC AE v 4.0)<br /><br>- Disease-specific and overall survival<br /><br>- Patient-reported quality of life</p><br>