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First Line TIP in Poor Prognosis TGCTs. (TIP)

Primary Purpose

Germ Cell Tumor

Status
Completed
Phase
Phase 2
Locations
Slovakia
Study Type
Interventional
Intervention
Paclitaxel
Ifosfamide
Cisplatin
Sponsored by
National Cancer Institute, Slovakia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Germ Cell Tumor focused on measuring poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intravenous chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Complete response rate
according RECIST criteria version 1.1

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2015
Last Updated
August 5, 2020
Sponsor
National Cancer Institute, Slovakia
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1. Study Identification

Unique Protocol Identification Number
NCT02414685
Brief Title
First Line TIP in Poor Prognosis TGCTs.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Slovakia

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Germ Cell Tumor
Keywords
poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intravenous chemotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
paclitaxel ebewe
Intervention Description
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
ifosfamide-holoxan
Intervention Description
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
cisplatin-hospira
Intervention Description
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
Primary Outcome Measure Information:
Title
Complete response rate
Description
according RECIST criteria version 1.1
Time Frame
36 month
Secondary Outcome Measure Information:
Title
Response rate
Description
response rate after chemotherapy
Time Frame
36 month
Title
Progression-free survival
Description
expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate
Time Frame
36 month
Title
Number of adverse events grade III and IV
Time Frame
36 month
Title
overall survival
Description
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.
Time Frame
36 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Mego, Ass.prof
Organizational Affiliation
National Cancer Institute, Slovakia
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Institute
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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First Line TIP in Poor Prognosis TGCTs.

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