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Trial record 24 of 1645 for:    Slovakia

First Line TIP in Poor Prognosis TGCTs. (TIP)

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ClinicalTrials.gov Identifier: NCT02414685
Recruitment Status : Recruiting
First Posted : April 13, 2015
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Germ Cell Tumor Drug: Paclitaxel Drug: Ifosfamide Drug: Cisplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intravenous chemotherapy

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
Drug: Paclitaxel
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
Other Name: paclitaxel ebewe

Drug: Ifosfamide
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
Other Name: ifosfamide-holoxan

Drug: Cisplatin
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
Other Name: cisplatin-hospira




Primary Outcome Measures :
  1. Complete response rate [ Time Frame: 36 month ]
    according RECIST criteria version 1.1


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 36 month ]
    response rate after chemotherapy

  2. Progression-free survival [ Time Frame: 36 month ]
    expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate

  3. Number of adverse events grade III and IV [ Time Frame: 36 month ]
  4. overall survival [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414685


Contacts
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Contact: Jozef Mardiak, Prof +421259378 ext 366 jozef.mardiak@nou.sk
Contact: Michal Mego, Ass.prof. +421259378 ext 366 misomego@nou.sk

Locations
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Slovakia
National Cancer Institute Recruiting
Bratislava, Slovakia, 83310
Contact: Michal Mego, Assoc. Prof    +421259378 ext 366    michal.mego@nou.sk   
Contact: Jozef Mardiak, Prof    +421259378 ext 108    jozef.mardiak@nou.sk   
Principal Investigator: Jozef Mardiak, Prof         
Principal Investigator: Michal Mego, Assoc. Prof         
Sponsors and Collaborators
National Cancer Institute, Slovakia
Investigators
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Study Chair: Michal Mego, Ass.prof National Cancer Institute, Slovakia

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Responsible Party: National Cancer Institute, Slovakia
ClinicalTrials.gov Identifier: NCT02414685     History of Changes
Other Study ID Numbers: GCTSK003
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by National Cancer Institute, Slovakia:
poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents