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

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

NCT Number	NCT02305654
Lead Sponsor	Institute of Cancer Research, United Kingdom Collaborators: National Cancer Institute (NCI), ECOG-ACRIN Cancer Research Group
Conditions	Squamous Cell Carcinoma of the Penis, Usual Type
Enrollment	200 participants
Start Date	2017-05-12
Primary Completion	2027-05-31 (estimated)
Study Completion	2027-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-02