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

Recruiting now · Phase 3

Conditions studied: Squamous Cell Carcinoma of the Penis, Usual Type

In brief

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

Key facts

Study ID

NCT02305654

Run by

Institute of Cancer Research, United Kingdom

People needed

200

Starts

2017-05-12

Expected to finish

2027-11-30

Last updated by the study team

2025-04-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Measurable disease as determined by RECIST (version 1.1) criteria;
• Histologically-proven squamous cell carcinoma of the penis,
• 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
• Performance Status ECOG 0, 1 or 2.

You may not qualify if…

• Pure verrucous carcinoma of the penis,
• Nonsquamous malignancy of the penis,
• Squamous carcinoma of the urethra,
• Stage M1,
• Previous chemotherapy or chemoradiotherapy,
• 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.

Where it is running

• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Velindre NHS Trust — Cardiff, United Kingdom (enrolling)
• University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• St George's Hospital NHS Foundation Trust — London, United Kingdom (enrolling)
• Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich, United Kingdom (enrolling)
• Los Angeles County-USC Medical Center — Los Angeles, California, United States (enrolling)
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Swansea Bay University Health Board — Swansea, United Kingdom
• Grady Health System — Atlanta, Georgia, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• The Royal Marsden NHS Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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