International Study on Advanced Penile Cancer Treatment Options
Sponsor: Institute of Cancer Research, United Kingdom
ClinicalTrials ID:NCT02305654
This international clinical trial is exploring different treatment options for advanced penile cancer, focusing on patients with cancer that has spread to the groin lymph nodes. The study aims to find the best treatment sequence to improve patient outcomes.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing different treatment approaches for advanced penile cancer, specifically for patients whose cancer has spread to the lymph nodes in the groin area. The trial involves two stages of randomization to determine the most effective treatment sequence. Patients are divided into groups based on the extent of their disease, as seen in scans. They may receive one of three initial treatments: standard surgery, chemotherapy followed by surgery, or a combination of chemotherapy and radiation followed by surgery. After surgery, patients are assessed for their risk of cancer returning. Those at high risk may receive additional treatment to prevent cancer from spreading to the pelvis.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to participate.
- Have cancer that can be measured using specific medical criteria.
- Diagnosed with squamous cell carcinoma of the penis.
- Cancer stage includes:
- Any tumor size with a single movable groin lymph node, no distant spread.
- Any tumor size with multiple or both sides groin lymph nodes, no distant spread.
- Any tumor size with fixed groin lymph node mass or pelvic lymph node involvement, no distant spread.
- Must be in relatively good health with a performance status score of 0, 1, or 2.
Exclusion Criteria
- Have a type of penile cancer called pure verrucous carcinoma.
- Have a non-squamous type of penile cancer.
- Have squamous cell cancer of the urethra.
- Cancer has spread to distant parts of the body (Stage M1).
- Have had previous chemotherapy or chemoradiotherapy.
- Have another type of cancer (except certain skin cancers) that required treatment in the last 3 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles County-USC Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Grady Health System | 30303 | Atlanta | Georgia |
| Emory University Hospital/Winship Cancer Institute | 30322 | Atlanta | Georgia |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| University of Oklahoma Health Sciences Center | 73104 | Oklahoma City | Oklahoma |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
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