Treatment
This study consists of two different treatment options:
Standard treatment arm 1: Primary chemoradiation
Experimental treatment arm 2: NACT (3-weekly carboplatin and paclitaxel) followed by surgery
Patients will be randomized (1:1).
Eligibility
Main inclusion criteria:
Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib – IVa, T1b or higher, any N, M0.
Local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of extensive surgery (meaning surgery damaging pelvic organs or exenterative surgery). This can imply:
- T1b or larger tumour with (irresectable) groin metastases
- T1b or larger tumour with a close relationship to and/or involvement of the urethra or anal sphincter
Main exclusion criteria:
Patients with highly suspicious or positive metastases to the pelvic lymph nodes
Patients eligible for radical local excision without involvement of other organs
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT04192253). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be