International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

To join this study, you generally need to be a male adult aged 18 or older with a specific type of penile cancer called squamous cell carcinoma. This cancer must have spread to the lymph nodes in your groin area, which doctors can usually feel. However, it must not have spread to other distant parts of your body. Your general health also needs to be good enough to undergo the treatments in the study.

There are certain reasons why you wouldn't be able to join. For example, if you have a very rare type of penile cancer called pure verrucous carcinoma, or if you have another type of cancer in your penis or urethra. You also can't have had chemotherapy or chemoradiotherapy in the past for this particular cancer, and the cancer must not have spread to distant parts of your body. Also, if you've had certain other cancers treated in the last three years, you might not be able to participate.

If you join this study, your initial treatment will be decided by chance by a computer (like flipping a coin). You could receive either standard surgery to remove lymph nodes in your groin, or chemotherapy drugs followed by that surgery, or chemotherapy combined with radiotherapy followed by that surgery. The chemotherapy involves drugs like Paclitaxel, Ifosfamide, and Cisplatin, often given in cycles. The radiotherapy is a special type called IMRT, which precisely targets the cancer.

After this first stage, doctors will examine the removed lymph nodes under a microscope. Depending on what they find, you might then enter a second part of the study. In this second part, if your risk of the cancer returning is high, you would again be randomly assigned to either have an additional surgery to remove lymph nodes in your pelvis, or not have that extra surgery. The total duration of your participation, including follow-up appointments, would be discussed fully by the study team.