First Line TIP in Poor Prognosis TGCTs.

Germ Cell Tumor Clinical Trial

— TIP  

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 Details — Status: Completed

Administrative data

• NCT number: NCT02414685
• Other study ID #: GCTSK003
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: June 2020

Study information

• Verified date: August 2020
• Source: National Cancer Institute, Slovakia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 16 years.

• Evidence of NSGCT based on histologic examination or based on clinical evidence and high serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are very elevated)

• Testicular, retroperitoneal, or mediastinal primary site.

• Evidence of disseminated disease (clinical stages II or III).

• Disease classified as poor prognosis according to IGCCCG criteria:

• Primary mediastinal NSGCT or

• Non-pulmonary visceral metastases or

• HCG > 50,000 UI/l, or AFP > 10,000 ng/ml, or LDH > 10 times the upper normal value.

• No prior chemotherapy.

• No previous carcinoma, except basal-cell carcinoma of the skin.

• Adequate renal function: measured or calculated creatinine clearance> 60 ml/min.

• Absolute granulocyte count >= 1,500/mm3, platelets >= 100,000 mm3, bilirubine <= 1.5 fold the upper normal value.

• Unfavorable tumor marker decline after 1.cycle of BEP

• Signed informed consent.

Exclusion Criteria:

• Patients infected by the Human Immunodeficiency Virus (HIV).

• Patients who do not fit inclusion criteria.

Related Conditions & MeSH terms

• Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal

Intervention

Drug:
• Paclitaxel
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
• Ifosfamide
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
• Cisplatin
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements

Locations

Country	Name	City	State
Slovakia	National Cancer Institute	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Slovakia

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate	according RECIST criteria version 1.1	36 month
Secondary	Response rate	response rate after chemotherapy	36 month
Secondary	Progression-free survival	expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate	36 month
Secondary	Number of adverse events grade III and IV		36 month
Secondary	overall survival	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.	36 months