First Line TIP in Poor Prognosis TGCTs.

Phase 2

Completed

• Conditions: Germ Cell Tumor
• Interventions: Drug: Paclitaxel; Drug: Ifosfamide; Drug: Cisplatin

• Registration Number: NCT02414685
• Lead Sponsor: National Cancer Institute, Slovakia

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-10
• Study First Posted: 2015-04-13
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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.

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Exclusion Criteria

• Patients infected by the Human Immunodeficiency Virus (HIV).
• Patients who do not fit inclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravenous chemotherapy	Paclitaxel	TIP regimen: * Paclitaxel 250 mg/ m2 iv on day 1 * Ifosfamide 1,2 g/ m2/ day iv x 5 days * Cisplatin 20 mg/ m2/ day iv x 5 days
intravenous chemotherapy	Ifosfamide	TIP regimen: * Paclitaxel 250 mg/ m2 iv on day 1 * Ifosfamide 1,2 g/ m2/ day iv x 5 days * Cisplatin 20 mg/ m2/ day iv x 5 days
intravenous chemotherapy	Cisplatin	TIP regimen: * Paclitaxel 250 mg/ m2 iv on day 1 * Ifosfamide 1,2 g/ m2/ day iv x 5 days * Cisplatin 20 mg/ m2/ day iv x 5 days

Primary Outcome Measures

Name	Time	Method
Complete response rate	36 month	according RECIST criteria version 1.1

Secondary Outcome Measures

Name	Time	Method
Response rate	36 month	response rate after chemotherapy
Number of adverse events grade III and IV	36 month
overall survival	36 months	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.
Progression-free survival	36 month	expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate

Trial Locations

Locations (1)

National Cancer Institute; 🇸🇰 Bratislava, Slovakia