First line TIP in poor prognosis TGCTs

Phase 1

• Conditions: Disseminated Non-Seminomatous Germ Cell Tumors.; MedDRA version: 21.1Level: PTClassification code 10061184Term: Germ cell cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001270-33-SK
• Lead Sponsor: árodný onkologický ústav

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-09
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

1.Signed informed consent.
2.Patients older than 18 years.
3.Evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are highly elevated)
4.Testicular, retroperitoneal, or mediastinal primary site.
5.Evidence of disseminated disease (clinical stages II or III).
6.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.
7.No previous malignancy, except for basal-cell carcinoma of the skin.
8.Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance> 60 ml/min.
9.Cockcroft formula: CrCl = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)]
10.Absolute neutrophil count ? 1,500/mm3, platelets ? 100,000 mm3, bilirubin ? 1.5x the upper limit of normal value.
11.Unfavorable tumor marker decline after 1.cycle of BEP in first line setting.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

Exclusion Criteria

1.Patients with known Human Immunodeficiency Virus (HIV) infection.
2.Patients who do not fit inclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified