Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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

Brief 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 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.


Sponsor: Chinese PLA General Hospital

Current Primary Outcome: Progression-free survival [ Time Frame: up to 12 months ]

Measure the time of progression-free from start of treatment, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall response rate [ Time Frame: every 2 cycles (6 weeks) until treatment discontinuation, an expected average of 1 year. ]
    The proportion of patients with a confirmed complete or partial response (CR or PR) according to RECIST v1.1. CR = disappearance of all target lesions. PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
  • Disease control rate [ Time Frame: change from baseline in tumor assessment at 18 weeks (cycle 6). ]
    Defined by RECIST criteria (version 1.1) as a percentage of best overall responses of CR+PR+SD.
  • Overall survival [ Time Frame: every 8 weeks until disease progression or death on study, an expected average of 2 years. Patients with progressive disease will be followed every 3 months for the first year and every 6 months thereafter up to 5 years. ]
    Measure of time from Day 1 of study drug administration to disease progression or death or lost to follow-up on study.
  • The number of treatment-emergent adverse events (AEs) and serous adverse events (SAEs) as a measure of safety [ Time Frame: every 3 weeks until treatment discontinuation plus 30 days, an expected average of 1 year. ]
    The reported incidence of AEs and SAEs with an onset on or after the initiation of therapy will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: February 9, 2017
Date Started: April 1, 2017
Date Completion: December 31, 2020
Last Updated: February 10, 2017
Last Verified: February 2017