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
Squamous Cell Carcinoma of the Penis, Usual Type
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
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
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Los Angeles County-USC Medical Center, Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033
Moffitt Cancer Center, Tampa, Florida, United States, 33612
Grady Health System, Atlanta, Georgia, United States, 30303
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States, 30322
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States, 60637
Mayo Clinic, Rochester, Minnesota, United States, 55905
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States, 43210
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, 19111
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
MALE
No
Institute of Cancer Research, United Kingdom,
Steve Nicholson, STUDY_CHAIR, Mid and South Essex NHS Foundation Trust
Curtis Pettaway, STUDY_CHAIR, University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; cpettawa@mdanderson.org
2027-11-30