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

Launched by INSTITUTE OF CANCER RESEARCH, UNITED KINGDOM · Nov 27, 2014

Keywords

ClinConnect Summary

The International Penile Advanced Cancer Trial is a research study designed to find the best treatment options for men with a specific type of cancer called squamous cell carcinoma of the penis. This trial is focused on patients who have cancer that has spread to the lymph nodes in the groin area. The study will explore different treatment paths, including standard surgery alone, chemotherapy followed by surgery, or a combination of chemotherapy and radiation followed by surgery. The goal is to help doctors understand which treatment works best for different patients based on how advanced their cancer is.

To participate in this trial, men aged 65 to 74 with a confirmed diagnosis of squamous cell carcinoma of the penis that has spread to the lymph nodes may be eligible. Participants will first receive one of the three initial treatment options and then be monitored to see if their cancer comes back. This study is important because it aims to provide new insights that can guide future treatment decisions for patients with advanced penile cancer. If you or a loved one is considering joining this trial, it’s essential to talk with your doctor about the potential benefits and risks.

Gender

MALE

Eligibility 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.