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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

NCT03051373 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-08-09

No results posted yet for this study

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.

Conditions

  • Carcinoma, Transitional Cell

Interventions

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.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2019-04-30
Completion
2020-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03051373 on ClinicalTrials.gov