A Phase II Trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic carcinoma of the penis - Penile TPF

The Institute of Cancer Research0 个研究点目标入组 29 人开始时间: 2009年4月16日最近更新: 2020年7月27日

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•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. T3, N1 patients) will depend on local policy – discussion within the MDT of all eligible patients will be encouraged.
•Inclusion criteria
•Male, >18 years
•Measurable disease as determined by RECIST criteria
•Histologically-proven squamous cell carcinoma of the penis
•Stage:M1, or;
•M0, any T, N3 (i.e. involvement of deep inguinal or pelvic lymph nodes) or;
•M0, any T, N2 (i.e. involvement of multiple or bilateral superficial lymph nodes) and deemed inoperable by MDT, or;
•M0, T3 N1 (tumour invades urethra or prostate and single inguinal lymph node involved) or;
•M0, T4 (tumour invades other adjacent structures) any N
•GFR greater or equal to 60ml/min
•Performance Status ECOG 0, 1 or 2
•Written, informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Pure verrucous carcinoma of the penis
•Squamous carcinoma of the urethra
•Patients who do not have measurable disease as determined by RECIST
•T1 N1 M0 disease
•T2 N1 M0 disease
•Unfit for this regimen (as assessed by the multidisciplinary team)
•Previous chemotherapy
•Previous radiotherapy (subsequent radiotherapy for loco-regional consolidation is permitted)
•Contraindication to chemotherapy
•No malignancy (other than Squamous Cell Carcinoma or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 5 years. All patients with a previous cancer diagnosis must be discussed with one of the Chief Investigators prior to entry into the trial.

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