International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 3
Details
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborators:
Canadian Cancer Trials Group ECOG-ACRIN Cancer Research Group European Organisation for Research and Treatment of Cancer - EORTC National Cancer Institute (NCI)