Ignite Creation Date:
2025-12-18 @ 8:36 AM
Ignite Modification Date:
2025-12-18 @ 8:36 AM
Study NCT ID:
NCT02414685
Status:
None
Last Update Posted:
2020-08-07 00:00:00
First Post:
2015-04-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First Line TIP in Poor Prognosis TGCTs.
Sponsor:
None
Organization:
Study Overview
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.
Status:
None
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIP
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: