Phase 2
Completed N=30
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis
Source: ClinicalTrials.gov NCT00512096 ↗Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants With Pathologic Complete Remission (pCR) — 3 participants
Summary
Primary Objective:
-To evaluate the feasibility and efficacy of multimodality treatment (neoadjuvant chemotherapy prior to extirpative surgery) for clinical stage TXN2-3M0 squamous cell carcinoma of the penis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pathologic Complete Remission (pCR) |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained from each patient prior to study entry.
- Age >/= 14 years of age. Life expectancy greater than or equal to 6 months. PS /= 1,500/mm3(superscript) and platelet count >/= 100,000/mm3. Transaminases /= 40ml/minute.
- No evidence of active ischemia on the EKG and, for patients with significant prior coronary artery disease history, an ejection fraction of more than 40%. No evidence of severe conduction abnormalities on EKG.
Exclusion Criteria
- Patients with uncontrolled infection or CNS disease.
- Distant metastasis (TNM stage M1, i.e., lung, bone, other visceral sites, lymph node metastasis above the aortic bifurcation).
- Patients with clinically negative inguinal examinations or those with palpable adenopathy not meeting pathological or clinical criteria (i.e., minimal nodal metastasis or false positive inguinal examination).
- Prior systemic chemotherapy for penile carcinoma.
- Prior radiation therapy to inguinal or pelvic lymph nodes.
Data sourced from ClinicalTrials.gov (NCT00512096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.