Status:
RECRUITING
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborating Sponsors:
National Cancer Institute (NCI)
ECOG-ACRIN Cancer Research Group
Conditions:
Squamous Cell Carcinoma of the Penis, Usual Type
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of t...
Eligibility Criteria
Inclusion
- Written informed consent
- Measurable disease as determined by RECIST (version 1.1) criteria;
- Histologically-proven squamous cell carcinoma of the penis,
- 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
- Performance Status ECOG 0, 1 or 2.
Exclusion
- Pure verrucous carcinoma of the penis,
- Nonsquamous malignancy of the penis,
- Squamous carcinoma of the urethra,
- Stage M1,
- Previous chemotherapy or chemoradiotherapy,
- 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.
Key Trial Info
Start Date :
May 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02305654
Start Date
May 12 2017
End Date
November 30 2027
Last Update
April 2 2025
Active Locations (17)
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1
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Grady Health System
Atlanta, Georgia, United States, 30303