Chemoradiation in vulvar cancer patients with metastases larger than 2mm in the sentinel node

Phase 1

Conditions: vulvar cancer patients with sentinel lymph node metastases larger than 2mm
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-003973-16-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 157

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
- Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures
. 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 82
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

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
- Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
- 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the safety of replacing inguinofemoral lymphadenectomy by adjuvant chemoradiation in early stage vulvar cancer patients with a macrometastasis (>2mm) or extracapsular spread in the sentinel lymph node;Secondary Objective: Evaluate the short and long-term morbidity associated with the sentinel node procedure and adjuvant chemosensitizing radiation;Primary end point(s): Number of groin recurrences within 2 years after primary treatment;Timepoint(s) of evaluation of this end point: Every three months during the first two years after completion of primary treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Short –and long term treatment related toxicity ;Timepoint(s) of evaluation of this end point: will be monitored and more detailed at 6, 12 and 24 month using Common Terminology Criteria for adverse events (NCI-CTCAE version 4.0, grade 0-5)