Participate in Research at CU Anschutz

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND

We want to see if we can improve the treatment of patients with penis cancer that has spread, like yours. The purpose of this study is to test treatments which might reduce the chances of the cancer coming back. Combinations of four different treatments are being studied: Surgery to remove the lymph nodes in the groin near to where your cancer first appeared. Chemotherapy followed by surgery. Chemotherapy combined with radiotherapy followed by surgery. Surgery to remove the lymph nodes in the groin and also lymph nodes further away from where your cancer first appeared (deeper in the pelvis). We want to know if having surgery after chemotherapy or after chemotherapy with radiotherapy is better than having surgery alone and whether having additional surgery to remove the lymph nodes that are further away from where your cancer first appeared is better than not having this additional surgery. Not every patient will receive every treatment. This study is taking part in a number of hospitals in North America together with hospitals across the United Kingdom and Europe. Approximately 151 men will take part in this study in North America. The overall accrual goal for this study is 200 patients.