International trial for advanced penile cancer treatment options
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
PHASE3 · Institute of Cancer Research, United Kingdom · NCT02305654
This study is testing different treatment options for men with advanced penile cancer to see which approach works best for them.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Institute of Cancer Research, United Kingdom (other) |
| Drugs / interventions | chemotherapy |
| Locations | 17 sites (Los Angeles, California and 16 other locations) |
| Trial ID | NCT02305654 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically-proven squamous cell carcinoma of the penis and inguinal lymph node metastases who meet specific staging and performance criteria.
Not a fit: Patients with pure verrucous carcinoma, nonsquamous malignancies of the penis, or those with metastatic disease (stage M1) will not benefit from this trial.
Why it matters
Potential benefit: If successful, this trial could provide more effective treatment options for patients with advanced penile cancer, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promise in similar treatment approaches for advanced penile cancer, but this trial's specific design and focus on treatment sequencing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California and 16 other locations
- 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)
- Grady Health System — Atlanta, Georgia, United States (ACTIVE_NOT_RECRUITING)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (RECRUITING)
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (ACTIVE_NOT_RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (ACTIVE_NOT_RECRUITING)
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (ACTIVE_NOT_RECRUITING)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (ACTIVE_NOT_RECRUITING)
- University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Velindre NHS Trust — Cardiff, United Kingdom (RECRUITING)
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (RECRUITING)
- The Royal Marsden NHS Foundation Trust — London, United Kingdom (ACTIVE_NOT_RECRUITING)
- St George's Hospital NHS Foundation Trust — London, United Kingdom (RECRUITING)
- Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich, United Kingdom (RECRUITING)
- Swansea Bay University Health Board — Swansea, United Kingdom (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: UK - InPACT Senior Trial Manager
- Email: InPACT-icrctsu@icr.ac.uk
- Phone: 02087224261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Squamous Cell Carcinoma of the Penis, Usual Type, Penis cancer, Chemotherapy, Chemoradiotherapy, Surgery, Phase III