Trials / Completed
CompletedNCT03051373
Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Chinese PLA General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited. The purpose of this study is to test in a randomized trial enrolling patients for comparing the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order to determine the most promising agents as the first line treatment of advanced and/or metastatic transitional cell carcinoma of urothelial tract.
Detailed description
Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited. The purpose of this study is to test in a randomized trial enrolling patients for comparing the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order to determine the most promising agents as the first line treatment of advanced and/or metastatic transitional cell carcinoma of urothelial tract.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nanoparticle albumin-bound paclitaxel, S-1 | Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles. |
| DRUG | Gemcitabine, cisplatin | Gemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles. |
Timeline
- Start date
- 2017-04-01
- Primary completion
- 2019-04-30
- Completion
- 2020-04-30
- First posted
- 2017-02-13
- Last updated
- 2021-08-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03051373. Inclusion in this directory is not an endorsement.