Vulvar Cancers

Vulvar squamous cell carcinoma is a rare cancer that is usually treated with surgery. Some patients need removal of lymph nodes from one or both groins, called inguinofemoral lymphadenectomy. The standard open operation can cause wound infections, wound separation, fluid collections, prolonged drainage, and swelling of the leg. These complications are especially important because many people with vulvar cancer are older and may have other health conditions. SP-RAIL is an international, multicenter, randomized phase 2 study comparing two surgical approaches to inguinofemoral lymphadenectomy. The study plans to enroll 64 adults with a new diagnosis of vulvar squamous cell carcinoma who require this lymph-node surgery. Participants will be assigned by chance in a 1:1 ratio to either single-port robot-assisted inguinofemoral lymphadenectomy or traditional open inguinofemoral lymphadenectomy. Both groups will receive lymph-node removal according to the same anatomical boundaries. Sentinel lymph-node mapping or biopsy may also be performed as described in the protocol. The main question is whether the single-port robotic approach reduces clinically important complications during the first 30 days after surgery. Complications will be graded using the Clavien-Dindo classification, and grades 2 to 5 will be included in the primary outcome. Reoperations for separation of the vulvar wound will not be counted as complications caused by the groin lymph-node procedure. The study will also compare operating time, blood loss, complications during surgery, conversion to another surgical approach, length of hospital stay, duration of drainage, number of lymph nodes removed, later treatment-related problems, symptoms of leg or groin lymphedema, quality of life, groin recurrence, recurrence-free survival, overall survival, and health-care costs. Participants will complete quality-of-life and lymphedema questionnaires before treatment and at specified times after treatment. Clinical follow-up will continue regularly through 24 months, and survival follow-up is planned through 60 months. An early safety and feasibility review will take place after the first 10 participants have entered the robotic surgery group. The study will stop if the median number of lymph nodes removed per groin in that group is fewer than six. Groin recurrences will be monitored throughout the study, and enrollment may be stopped if an unexpectedly high recurrence rate is observed.

The goal of this study is to compare pain during a vulvar biopsy using either the needle-free J-Tip device or the standard lidocaine shot. We expect to enroll up to 106 subjects will be enrolled in this study at Tufts Medical Center. The study will take place in a gynecology clinic or outpatient medical office where your biopsy is already scheduled. You will be asked to review and sign a consent form before joining the study. You will then complete a short survey about your background, pain level, and anxiety. During your visit, you will be randomly assigned (like flipping a coin) to receive numbing medicine either through a needle-free device (J-Tip) or a standard injection. The numbing medicine will be given before your vulvar biopsy. You will be asked to rate your pain and nervousness at different times at the beginning and after the procedure using a simple scale. After the biopsy, you will complete a short survey about your experience. Your doctor will also record details about the procedure. The day after your biopsy, you will be asked to complete one more short survey about your pain and overall experience.

This research will determine the impact of optimizing dosage and storage conditions for indocyanine green on health outcomes and will contribute to improving treatment processes in gynecological cancers. Ultrastaging will increase the detection of micrometastases. Furthermore, the cost impact of these optimizations will be evaluated. It will help develop more effective, safe, and cost-effective methods for sentinel lymph node mapping in gynecological cancers. Furthermore, significant savings in healthcare costs could be achieved.

This is a phase II, randomized study that will include 42 participants who have received 4 to 6 cycles of first-line platinum-based chemotherapy for advanced vulvar squamous cell carcinoma (SCC) not amenable to curative surgical treatment (FIGO 2018 stages III-IV - International Federation of Gynecology and Obstetrics) / recurrent disease, and who have not progressed at the end of these 4 to 6 cycles. Participants eligible for the study will be randomized between 4 and 8 weeks after the last chemotherapy cycle to receive: - Cemiplimab maintenance plus best supportive care: cemiplimab 350 mg IV every 3 weeks until week 24, disease progression, unacceptable toxicity or consent withdrawal. Patients who continue to derive clinical benefit on the experimental arm may continue to receive treatment until week 48. - Best supportive care.