A risk-adapted strategy of the use of dose-dense chemotherapy in patient with poor-prognosis dissemined non-seminomatous germ cell tumors. GETUG 13 / 0206

Phase 1

• Conditions: on-Seminoma Germ Cell Tumor; MedDRA version: 14.0Level: LLTClassification code 10018207Term: GerminomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-001072-13-DK
• Lead Sponsor: FNCLCC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-17
• Last Update Posted: 5 December 2016

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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