A phase II trial of docetaxel, cisplatin and 5-fluorouracil (5-FU) chemotherapy in locally advanced and metastatic carcinoma of the penis

Sponsor not yet defined (UK)0 个研究点目标入组 26 人开始时间: 2008年4月30日最近更新: 2018年11月19日

适应症

试验速览

•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.
•1. Male, >18 years
•2. Histologically-proven squamous cell carcinoma of the penis
•3. Eligible disease stage:
•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

•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

发起方

Sponsor not yet defined (UK)