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 ]
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