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ISRCTN
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ISRCTN78108737
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ClinicalTrials.gov identifier
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Public title
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A phase II trial of docetaxel, cisplatin and 5-fluorouracil (5-FU) chemotherapy in locally advanced and metastatic carcinoma of the penis
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Scientific title
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Acronym
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Penile TPF
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Serial number at source
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ICR-CTSU/2008/10016
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Study hypothesis
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The goal is to determine, in inoperable cancer of the penis, the feasibility and efficacy of giving chemotherapy consisting of two drugs that are known to be active (cisplatin and 5-fluorouracil [5-FU]) with a newer drug, docetaxel. This combination (TPF) has been proven to be highly active in some similar cancers. This is a limited phase II trial to gain insight into the potential activity of this regimen.
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Ethics approval
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To be submitted as of 30/01/2008.
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Study design
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Non-randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Penis cancer
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Participants - inclusion criteria
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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., 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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/06/2008
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Anticipated end date
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01/06/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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26
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Interventions
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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 in total prior to formal re-staging.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Cancer Research UK (decision pending as of 30/01/2008)
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Trial website
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Publications
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Contact name
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Dr
Amit
Bahl
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Address
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Bristol Haematology & Oncology Centre
Horfield Road
Bristol
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City/town
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Avon
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Zip/Postcode
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BS28ED
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Country
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United Kingdom
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Sponsor
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Sponsor not yet defined (UK)
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Address
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-
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City/town
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-
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Zip/Postcode
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-
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Country
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United Kingdom
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Date applied
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30/01/2008
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Last edited
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30/04/2008
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Date ISRCTN assigned
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30/04/2008
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