Clinical Trial: First Line TIP in Poor Prognosis TGCTs.

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

Official Title: A Treatment Strategy of the Use of 1st Line Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors Based on Tumor Marker Decline: A Ph

Brief Summary: TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Detailed Summary:

Cycle 1: BEP regimen

Serum tumor markers at day 18-21:

•Patients with an unfavorable pattern of tumor marker decrease after 1 cycle of BEP will receive 4 more cycles of TIP.

TIP regimen:

  • Taxol 250 mg/ m2 iv on day 1
  • Ifosfamid 1,2 g/ m2/ day iv x 5 days
  • Cisplatin 20 mg/ m2/ day iv x 5 days One cycle of therapy consists of 22 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Sponsor: National Cancer Institute, Slovakia

Current Primary Outcome: Complete response rate [ Time Frame: 36 month ]

according RECIST criteria version 1.1


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rate [ Time Frame: 36 month ]
    response rate after chemotherapy
  • Progression-free survival [ Time Frame: 36 month ]
    expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate
  • Number of adverse events grade III and IV [ Time Frame: 36 month ]
  • overall survival [ Time Frame: 36 months ]
    Survival will be estimated from the registration date to the date of last follow-up or death. Patients will be followed at least 3 years.


Original Secondary Outcome: Same as current

Information By: National Cancer Institute, Slovakia

Dates:
Date Received: April 8, 2015
Date Started: April 2015
Date Completion: June 2017
Last Updated: July 14, 2016
Last Verified: July 2016