Intensive chemotherapy for patient with germ cell tumors with poor prognosis.

Phase 1

• Conditions: on-Seminoma Germ Cell Tumor; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-001072-13-SK
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-20
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 260

Inclusion Criteria

1-Patients older than 16 years.
2-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 elevated)
3-Testicular, retroperitoneal, or mediastinal primary site.
4-Evidence of disseminated disease (clinical stages II or III).
5-Disease classified as poor prognosis according to IGCCCG criteria:
- Primary mediastinal NSGCT (any stage) 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.
6-No prior chemotherapy.
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.
Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)]
(for females, multiply by 0.85)
9-Absolute granulocyte count >or= 1,500/mm3, platelets > or = 100,000 mm3, bilirubine < or = 1.5x the upper limit of normal value.
10-Signed informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1-Patients infected by the Human Immunodeficiency Virus (HIV).
2-Patients who do not fit inclusion
3-Female patients.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the progression-free survival rates of patients with poor prognosis NSGCT and an unfavorable decrease of tumor markers after 1cycle of the BEP regimen, randomly treated either by 3 subsequent cycles of BEP or by a dose-dense regimen called T-BEP-Oxali/Plat-Ifo-Bleo;Secondary Objective: 1.To evaluate the response rate, overall survival rate and toxicity in both treatment groups (control and study group) with unfavorable decrease in the serum tumor markers.<br>2.To evaluate the response rate, progression-free survival, overall survival and toxicity in patients with a favorable decrease in the serum levels of tumor markers.<br> ;Primary end point(s): Primary: Progression-free survival<br>;Timepoint(s) of evaluation of this end point: -

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Response rate, overall survival and toxicity in the 2 arms<br>response rate, progression free survival, overall survival and toxicity in patients with a favorable decrease of tumors markers;Timepoint(s) of evaluation of this end point: -