New Strategy for the Treatment of Vulvar Cancer

Vulvar cancer is a rare disease that is treated with surgery, radiation and chemotherapy. When tumors are large (greater than 4 cm) or compromise the urethra (urine canal) and the anus, or when it is in the groin lymph nodes, surgery alone is not always able to be performed. In this circumstance, is necessary to add radiotherapy, chemotherapy or both . So far it is not known the best sequence of treatment: surgery, chemotherapy or radiotherapy. The radical surgeries usually need long recovery term both in the region of the vulva and in the region of the groin lymph nodes. When it is performed, convalescence can delay other treatments, like radiotherapy and chemotherapy. On the other hand, the use of radiotherapy and chemotherapy as a first step treatment can result in a complete elimination of the disease in at least 30% of the cases or substantial reduction of its size, allowing less extensive surgery. Investigators intend to use surgery, chemotherapy and radiotherapy in the treatment of vulvar cancer, but in a sequence that has not been studied, in order to increase benefits of these treatments, and reduce morbidity. This study will be offered to patients who have disease of the vulva less than 4 cm (sentinel lymph node), or greater than 4 cm, or illness that compromises urethra and anus, or patients with disease in groin lymph nodes (glands). 1. On the eve of the surgery, investigators will inject dextran-70 labeled with technetium-99 m. Only patients with tumors smaller than 4 cm will do this procedure. 2. On the day of the surgery, the groin lymph nodes will be removed from the inguinal (groin) only. If lymph nodes are disease positive, the vulvectomy will not be performed at this time. Patients will be treated with radiation therapy with concomitant chemotherapy for approximately six weeks. 3. At the end of treatment with chemotherapy and radiotherapy, investigators will perform a surgery to remove the remaining tumor in the vulva.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Patients with histological diagnosis of squamous cell carcinoma of the vulva;
* Performance status 0-3 (ECOG);
* Adequate bone marrow function, liver and kidney;

Exclusion Criteria:

\- Patients with a history of treatment of other invasive cancers in the last 5 years

• DERIVEDDias-Jr AR, Soares-Jr JM, de Faria MBS, Genta MLND, Carvalho JP, Baracat EC. Secondary healing strategy for difficult wound closure in invasive vulvar cancer: a pilot case-control study. Clinics (Sao Paulo). 2019;74:e1218. doi: 10.6061/clinics/2019/e1218. Epub 2019 Sep 2. PMID 31482981