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New Clinical Trial Hopes to Set Standards for Penile Cancer Treatment

  • Most people have never met someone who has been diagnosed with penile cancer, a condition that occurs when cancerous cells form on the tissues of the penis. That is because penile cancer is rare, with only about 2,200 new cases diagnosed each year in the United States.

    “Even specialized cancer centers like Fox Chase may see less than 10 cases a year,” said Marc C. Smaldone, MD, MSHP, FACS, an Associate Professor in Fox Chase’s Department of Surgical Oncology.

    Currently, there are four types of treatment used for penile cancer, but because the disease is rare, questions remain about which of these treatments (and in what order) are the best option.

    To answer this question, Fox Chase and other research centers across the country have opened the InPACT clinical trial.

    Who can enroll?

     The InPACT trial is designed to look at treatments for men with penile cancer that has spread to the lymph nodes in the groin (the area between the legs) or the pelvis (the area between the hip bones).

    To enroll, men must have:

    • A specific type of penile cancer called squamous cell penile cancer
    • Cancer that has spread to the lymph nodes
    • Cancer that has not spread beyond the lymph nodes to other parts of the body
    • Not received previous treatment for their penile cancer

    Interested patients should talk with their doctor to see if they qualify.

    What will the InPACT trial test?

    The InPACT trial has two parts. Part one involves receiving one of the following treatment regimens:

    • Surgery to remove the lymph nodes in the groin near where the cancer first appeared
    • Chemotherapy then surgery to remove the lymph nodes in the groin near where the cancer first appeared 
    • Chemoradiotherapy—a combination of chemotherapy and radiation—followed by surgery to remove the lymph nodes in the groin near where the cancer first appeared

    In part two, men found to have high risk of disease recurrence after receiving treatment in part one will also receive either surgery to remove lymph nodes deeper in the pelvis and chemoradiotherapy (if they have not already had it) or just chemoradiotherapy (if they have not already had it).

    “This trial is so important because a large proportion of patients with penile cancer are not receiving guideline-recommended care,” Smaldone said. “InPACT will help establish appropriate guidelines and make sure that these patients receive the most up-to-date standard of care.”

    We’re here to help

    Fox Chase is currently the only center of excellence enrolling patients in the Mid-Atlantic area for the InPACT trial. This includes Pennsylvania, New Jersey, Delaware, Maryland, and downstate New York.

    “We are the only local center of excellence offering the InPACT trial,” said Daniel M. Geynisman, MD, an Assistant Professor in Fox Chase’s Department of Hematology/Oncology and the primary investigator of the study at Fox Chase. “Our goal is to get the vast majority of patients with penile cancer in the area enrolled, as this is a great opportunity for patients with this rare disease.”

    To find out more about penile cancer or the InPACT trial, contact Fox Chase’s Clinical Trials Office at 215-214-1515.

    Learn more about penile cancer treatment at Fox Chase Cancer Center.