VinCaP
Research type
Research Study
Full title
A Phase II Trial of Vinflunine chemotherapy in locally advanced and metastatic carcinoma of the penis
IRAS ID
108709
Contact name
Lisa Pickering
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2012-002592-34
ISRCTN Number
n/a
Research summary
Cancer of the penis is rare. The UK annual incidence is 1.4 cases/100,000 with 519 new cases in 2009 and 92 deaths in 2010. The rarity of penile cancer means that there are very few prospective clinical trials investigating its management.
The majority (>95%) of cases of invasive cancer of the penis are squamous cell carcinoma (SCC). A substantial minority of penile cancers are of the verrucous subtype which has a better prognosis and may be suitable for a more conservative management policy. Rarer histology includes basal cell carcinoma, melanoma and neuroendocrine cancer; such tumours should be managed along guidelines described for those cutaneous tumours in other sites, with modifications accounting for location.
Distant metastatic disease is incurable. Combination chemotherapy is only recommended in symptomatic patients with good performance status, often in combination with other palliative procedures. This is based on the subjective improvements in quality of life that attend objective response. There is no good evidence that chemotherapy confers survival benefit for metastatic disease, although studies are few. Patients are predominantly over 60 years of age with various co-morbidities and a treatment is needed that improves quality of life and overall disease control with manageable toxicity. This trial investigates the use of vinflunine as drug treatment for patients with inoperable (metastatic or locally-advanced) SCC of the penis.REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/0822
Date of REC Opinion
12 Jul 2013
REC opinion
Favourable Opinion