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

Condition: Squamous Cell Carcinoma of the Penis, Usual Type

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02305654

Sponsor: Institute of Cancer Research, United Kingdom

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

View trial on ClinicalTrials.gov