Condition: Squamous Cell Carcinoma of the Penis, Usual Type · Sponsor: Institute of Cancer Research, United Kingdom
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
This description comes directly from the study's public registry record.
UK - InPACT Senior Trial Manager · 02087224261 · InPACT-icrctsu@icr.ac.uk
US/Canada - InPACT DA for EA8134 · (857)504-2900
Always discuss trial participation with your own doctor first.
| Los Angeles County-USC Medical Center | Los Angeles, California, United States | Recruiting |
| USC / Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
| Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| Grady Health System | Atlanta, Georgia, United States | Active Not Recruiting |
| Emory University Hospital/Winship Cancer Institute | Atlanta, Georgia, United States | Recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago, Illinois, United States | Active Not Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus, Ohio, United States | Active Not Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, United States | Active Not Recruiting |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania, United States | Active Not Recruiting |
| University of Texas M.D. Anderson Cancer Center | Houston, Texas, United States | Recruiting |
| Velindre NHS Trust | Cardiff, United Kingdom | Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02305654