Miscellaneous
Phase III
Adults
Chemotherapy - cytotoxic,
Radiotherapy,
Surgery
Cisplatin,
Ifosfamide,
Paclitaxel
Rini, Brian
International
Vanderbilt University
02-16-2024
Eligibility
Not Available
Not Available
Not Available
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.
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.
