Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT01728233
Eligibility Criteria:
Inclusion Criteria:
* Patients must provide written informed consent
* Eastern Cooperative Oncology Group performance status of at least 1
* Cytologically or histologically proven diagnosis of SCC of the penis
* Uni- or bidimensionally measurable disease as defined by RECIST v1.1 criteria
* Clinical stage N2-3 and/or M1 (TNM 2002)
* Locoregional relapse after prior major surgery/ies (either single or multiple)
* No prior systemic therapy except for the administration of vincristine-bleomycin-methotrexate (VBM) chemotherapy for superficial disease if administered at least 6 months prior to study enrollment
* Adequate bone marrow, liver and renal function
Exclusion Criteria:
* Central nervous system (CNS) metastases or leptomeningeal carcinomatosis
* History of active serious cardiovascular, cerebrovascular, pulmonary co-morbidities
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated \> 5 years prior to study entry.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01728233
Study Brief:
Protocol Section:
NCT01728233