Spots Global Cancer Trial Database for First Line TIP in Poor Prognosis TGCTs.

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Trial Identification

Brief Title: First Line TIP in Poor Prognosis TGCTs.

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.

Study ID: NCT02414685

Conditions

Germ Cell Tumor

Interventions

Paclitaxel

Ifosfamide

Cisplatin

Study Description

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 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.