Clinical Trial: Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Phase II Trial of Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-Risk Favorable best response is defined as complete response or partial response with negative tumor markers. Patients will be considered evaluable for the primary endpoint of favorable response within the first 6 months if they complete at least 3 cycles of study treatment (without switch to an alternative chemotherapy regimen) and achieve a confirmed partial response with negative markers or confirmed complete response (considered as favorable responses). Patients will also be considered evaluable for the primary endpoint if they develop disease progression during the treatment portion of the study regardless of how many cycles of chemotherapy they received or if they achieve an incomplete response after completion of study treatment (considered as not having a favorable response)."



Original Primary Outcome: favorable best response rate [ Time Frame: 6 months ]

Favorable best response is defined as complete response or partial response with negative tumor markers. Patients will be considered evaluable for the primary endpoint of favorable best response if they develop progression of disease at any time point after initiation of chemotherapy (these patients will be categorized as incomplete responders and therefore as having not achieved a favorable response).


Current Secondary Outcome:

  • overall best response [ Time Frame: 3 years ]
    Overall best response refers to the best response achieved by a patient to either TIP or BEP over the course of the entire study.
  • progression-free survival (PFS) [ Time Frame: 3 years ]
    Progression-free survival (PFS) will be calculated from the date of treatment start until disease progression, death, or last followup, whichever comes first. The following are included as PFS events: incomplete response (IR), relapse or disease progression, and death.
  • overall survival (OS) [ Time Frame: 3 years ]
    Overall survival will be calculated from the date of treatment start until death, regardless of the cause.
  • toxicity [ Time Frame: 30 days after completion of the last cycle of chemotherapy. ]
    Toxicity will be assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade of each toxicity will be recorded for each patient over the course of treatment (all cycles). Special emphasis will be placed on comparisons of the frequency of Grade 3/4 toxicities between the TIP and BEP arms.


Original Secondary Outcome:

  • overall best response [ Time Frame: after 4 cycles of chemotherapy ]
    Overall best response refers to the best response achieved by a patient to either TIP or BEP over the course of the entire study.
  • progression-free survival (PFS) [ Time Frame: 1 year ]
    Progression-free survival (PFS) will be calculated from the date of treatment start until disease progression, death, or last followup, whichever comes first. The following are included as PFS events: incomplete response (IR), relapse or disease progression, and death.
  • overall survival (OS) [ Time Frame: 1 year ]
    Overall survival will be calculated from the date of treatment start until death, regardless of the cause.
  • toxicity [ Time Frame: 1 year ]
    Toxicity will be assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade of each toxicity will be recorded for each patient over the course of treatment (all cycles). Special emphasis will be placed on comparisons of the frequency of Grade 3/4 toxicities between the TIP and BEP arms.


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: June 5, 2013
Date Started: June 2013
Date Completion: June 2018
Last Updated: January 24, 2017
Last Verified: January 2017