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InPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative study)
The purpose of this study is to determine 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 the cancer first appeared is better than not having this additional surgery. Not every participant will receive every study treatment.
Primary Objective: Two questions regarding the management of patients with locally-advanced squamous carcinoma of the penis are addressed as primary objectives: 1. (a) Is there a role for neoadjuvant therapy and, if so, (b) does chemotherapy or chemoradiotherapy produce superior outcomes (either for survival endpoints or for morbidity/quality of life endpoints)? 2. What is the additional survival benefit of prophylactic pelvic lymph node dissection (PLND) given after neoadjuvant chemoradiotherapy or with adjuvant chemoradiotherapy of the pelvic nodes over and above that of chemoradiotherapy alone in patients at high risk of recurrence following ILND? These questions are address through sequential randomisations (InPACT-neoadjuvant and InPACT-pelvis) at two key decision points in the clinical management pathway. Secondary Objectives: In InPACT-neoadjuvant: -Can neoadjuvant therapy prior to surgery (ILND) reduce recurrence rates? -Which is the more active of neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy? -What is the operative/post-operative complication rate following neoadjuvant therapy of both types? -Is neoadjuvant chemoradiotherapy feasible in this setting? In InPACT-pelvis: -What is the rate of additional complications for the combination of PLND and chemoradiotherapy? Exploratory Objectives: Two additional questions will be addressed, in participating patients: -What is the relationship between human paillomavirus (HPV) status and outcome for all groups studied? -What is the impact on quality of life of the (sequential) treatments studied?