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

Principal Investigator

Chad Ritch

Clinical Trial ID

Institutional Protocol # 20180363
National Clinical Trials Identifier NCT02305654

Clinical Trial Summary


Phase 3

Funding Agency/Sponsor

National Cooperative Group


Prostate, Bladder, and Kidney Cancers

Enrollment Eligibility

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
- 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.

Contact Information

Phone Number 305-243-9674
Get detailed information on ClinicalTrials.Gov