Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Medical Center Groningen
About this trial
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological confirmed primary SCC of the vulva
T1 tumor, not encroaching urethra/vagina/anus
Depth of invasion > 1mm
Tumor diameter < 4cm
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Radiotherapy combined with cisplatin
RadiationInguinofemoral radiotherapy combined with weekly cisplatin
Cisplatin
DrugInguinofemoral radiotherapy combined with weekly cisplatin
Treatment groups
157 Participants
are divided into 1 treatment groupGroup A: ChemoradiationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Groin recurrence rate
Groin recurrence in the groin with SN metastasis treated with chemoradiation
Time frame
Within first 2 years after primary treatmentSecondary outcomes
1
Treatment related morbidity
Short and longterm morbidty
Time frame
First two years after primary treatment2
Quality of life as assessed using EORTC-QLQc30
Quality of life
Time frame
First two year after primary treatment3
Quality of life-vulvar cancer specific, as assessed using VU34
Quality of life-vulvar cancer specific
Time frame
First two year after primary treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
Dutch Cancer Society
Collaborator
NRG Oncology
Collaborator
Source ClinicalTrials.gov