International trial for advanced penile cancer treatment options

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international phase III trial investigates treatment sequencing for patients with squamous cell carcinoma of the penis, focusing on those with inguinal lymph node metastases. The study employs a Bayesian design with two sequential randomizations to evaluate three treatment options: standard surgery, neoadjuvant chemotherapy followed by surgery, and neoadjuvant chemoradiotherapy followed by surgery. Patients are stratified based on disease burden assessed by radiological criteria, allowing for tailored treatment allocation. The trial aims to generate data that will inform future clinical decisions in managing this rare cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• University of Texas M.D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: UK - InPACT Senior Trial Manager
• Email: InPACT-icrctsu@icr.ac.uk
• Phone: 02087224261

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.