Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
National Cooperative Group
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment Eligibility
Inclusion Criteria:
1. Written informed consent
2. Measurable disease as determined by RECIST (version 1.1) criteria;
3. Histologically-proven squamous cell carcinoma of the penis,
4. Stage:
- any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
- any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0
or;
- any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0
5. Performance Status ECOG 0, 1 or 2.
Exclusion Criteria:
1. Pure verrucous carcinoma of the penis,
2. Nonsquamous malignancy of the penis,
3. Squamous carcinoma of the urethra,
4. Stage M1,
5. Previous chemotherapy or chemoradiotherapy,
6. Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that
has required surgical or non-surgical treatment in the last 3 years.