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First Line TIP in Poor Prognosis TGCTs. — TIP  

Germ Cell Tumor Clinical Trial

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 Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02414685
Study type Interventional
Source National Cancer Institute, Slovakia
Contact
Status Completed
Phase Phase 2
Start date April 2015
Completion date June 2020
View Details
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