Summary
Standard treatment for early stage vulvar cancer is wide local excision (surgical removal) of the primary tumour combined with the sentinel node (SN) procedure for the groinds. An inguinogemoral lymphadenectomy (IFL) is only indicated (recommended) in the case of a positive SN. An IFL is associated with major morbility, e.g. wound healing problems, lymphoceles, lymphoedema of the legs and recurrent infections.
A previous clinical trial called GROINSS-V II investigated whether radiation therapy would be a safe alternative for IFL in the case of SN metastatsis. The results for the radiation therapy group with metastasis ≤2mm are promising. The study also showed that for metastasis >2mm, only administering radiation therapy was not sufficient. The efficacy of treatment can be increased by adding chemotherapy or giving a higher dose of radiation therapy. This is what this current study is investigating: whether chemoradiation is safe and more effective than the surgical procedure IFL.
What does this study invovle?
Eligible participants will be treated with a chemoradiation, in a total dose of 56Gy to the involved site, combinde with weekly cisplatin at a dose of 40mg/m2.
Participants will be treated with chemoradiation during 5 weeks instead of surgical treatment. There is a risk that this treatment will not be as effective as surigical treatment, which may lead to more groin recurrences which are hard to treat. By continuously monitoring the groin recurrence rate the investigators will notice activation of the stopping rule as early as possible.