Jasint-2
Research type
Research Study
Full title
Randomized phase III study comparing vinflunine-gemcitabine and gemcitabine-carboplatin combinations in patients ineligible to cisplatin with advanced or metastatic urothelial carcinoma.
IRAS ID
193989
Contact name
Christel LUCAS
Contact email
Sponsor organisation
PIERRE FABRE MEDICAMENT
Eudract number
2014-005396-82
Duration of Study in the UK
4 years, 2 months, 31 days
Research summary
Transitional Cell Carcinoma of the urothelium, generally called urothelial carcinoma (UC) is the most frequent type of cancer developing in the urinary tract, located mainly in bladder. Bladder cancer counts for 430000 new cases per year worldwide. Radical cystectomy is the recommended treatment in non-metastatic bladder cancer. Unfortunately, up to 40% of patients will develop distant metastases.
In this case the standard treatment is chemotherapy based on Cisplatin. However, about 50% of the patients are not eligible for Cisplatin generally due to impaired renal function or poor general condition. There is no standard treatment for this population. The most commonly used treatment is combination of two chemotherapeutic agents, Gemcitabine and Carboplatin.
Vinflunine a chemotherapeutic already approved for treatment of UC in patients who have relapsed after treatment with platinum-based chemotherapy, provides survival advantage over best supportive care.
A clinical trial has assessed the benefit/risk ratio of two vinflunine-based regimens, Vinflunine-Gemcitabine and Vinflunine-Carboplatin in patients ineligible to Cisplatin. Both regimens have shown similar efficacy and a tolerability profile favoured the Vinflunine-Gemcitabine combination. Moreover, the combination of Vinflunine-Gemcitabine was compared favourably to published data on the preferred combination Gemcitabine-Carboplatin.
Thus, we propose this clinical trial, which is a randomized trial for adults with advanced or metastatic UC who cannot receive Cisplatin. This study will compare the efficacy and safety of patients treated with Gemcitabine-Carboplatin and those treated with Vinflunine-Gemcitabine.The study will be conducted in hospital sites worldwide and could last up to 56 months. The participants will undergo study assessments as required in the study Protocol.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0054
Date of REC Opinion
21 Mar 2016
REC opinion
Further Information Favourable Opinion