NCT02414685

First Line TIP in Poor Prognosis TGCTs.

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 Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Cancer Institute, Slovakia · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	Paclitaxel	paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
DRUG	Ifosfamide	paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
DRUG	Cisplatin	paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2015-04-13
• Last updated: 2020-08-07

Locations

1 site across 1 country: Slovakia