Penis cancer Cancer Penis cancer
Conditions
Interventions
All participants will receive the same regimen. The regimen consists of docetaxel 75 mg/m2 day 1 + cisplatin 60 mg/m2 day 1 + 5FU 750 mg/m2 days 1-5 with a cycle of 21 days, three cycles to be given i
Sponsors
Sponsor not yet defined (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients with cancer of the penis fit to receive chemotherapy as palliative or definitive treatment or as treatment on relapse will be eligible. It is expected that the decision to include some groups of patients (e.g., Stage T3, N1 patients) will depend on local policy - discussion within the multidisciplinary Team (MDT) of all eligible patients will be encouraged. Inclusion criteria: 1. Male, >18 years 2. Histologically-proven squamous cell carcinoma of the penis 3. Eligible disease stage: 3.1. M1 3.2. M0, Tx, N3 (i.e. involvement of deep inguinal or pelvic lymph nodes) 3.3. M0, Tx, N2 (i.e. involvement of multiple or bilateral superficial lymph nodes) and deemed inoperable by MDT 3.4. M0, T3 N1 (tumour invades urethra or prostate and single inguinal lymph node involved) 3.5. M0, T4 (tumour invades other adjacent structures) (any N) 4. Glomerular filtration rate (GFR) greater or equal to 60 ml/min 5. Written, informed consent
Exclusion criteria
Exclusion criteria: 1. Pure verrucous carcinoma of the penis 2. Squamous carcinoma of the urethra 3. T1 N1 M0 disease 4. T2 N1 M0 disease 5. T3 N1 M0 where the MDT feels that neoadjuvant chemotherapy is not advisable 6. Unfit for this regimen (as assessed by the MDT) 7. Previous chemotherapy 8. Previous radiotherapy (subsequent radiotherapy for loco-regional consolidation is permitted) 9. Contraindication to chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (complete remission rate + partial remission rate). This will be objectively assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan after completion of the proposed 3 cycles of TPF chemotherapy or at the time of discontinuation of chemotherapy. Scans will be reviewed centrally to confirm outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with inoperable locoregional disease rendered operable by TPF chemotherapy. Timepoints of measurement not yet defined as of 30 January 2008 2. Progression-free survival. Timepoints of measurement not yet defined as of 30 January 2008. 3. Overall survival. Duration of follow-up not yet defined as of 30 January 2008. 4. Acute toxicity (as determined by Common Toxicity Criteria [CTC]) after each cycle and at 3 months 5. Late toxicity (CTC). Timepoints of measurement not yet defined as of 30 January 2008. | — |
Countries
United Kingdom
Outcome results
None listed