E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with metastatic germ-cell tumors failing first-line treatment. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043302 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061378 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of high-dose chemotherapy plus stem-cell rescue (ASCT) using the carboplatin-etoposide (CE) regimen as initial salvage treatment of patients with relapsed or refractory germ-cell tumors (GCT). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the toxicity associated with high-dose chemotherapy and ASCT using CE for patients with relapsed or refractory GCT. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: Studio di espressione di biomarkers pre- e post-chemioterapia e correlazione con l`endpoint primario. Studio relativo alla PET. Correlazione tra la risposta PET e l`endpoint primario.
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E.3 | Principal inclusion criteria |
Age ≥ 18 years Male gender Histologic or clinical diagnosis of GCT. Unequivocal progression of measurable disease (measurable disease will consist of abnormalities on 2 dimensional imaging or raised tumor markers) following one line of cisplatin-based chemotherapy. IGCCCG-2 Good, Intermediate, Poor Relapser category. WBC ≥ 2000/�L with ANC ≥ 1500/�L. Platelets ≥ 100.000/�L. AST/ALT <2x ULN unless due to hepatic metastases in which case levels <5xULN are allowed. Total Bilirubin <1.5x ULN. Adequate cardiac function (EF ≥ 50% at echocardiogram). Negative Serology for the following infectious diseases: HBV, HCV, HIV, CMV. Written informed consent. |
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E.4 | Principal exclusion criteria |
Failure to meet any of the above inclusion criteria. Patients falling into the prognostic categories of “Very Good” and/or “Very Poor” relapsers according to the IGCCCG-2 scoring system. More than one prior line of cisplatin-based chemotherapy. Prior treatment with high-dose chemotherapy. ≥7 cycles of prior cisplatin-based chemotherapy. Concurrent treatment with other cytotoxic drugs or targeted therapies. Prior radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy. Inability to comply with the treatment protocol or to undergo the specified follow-up tests for safety or effectiveness. The existence of a concurrent malignancy (other than non-melanoma skin cancer). Patients with a prior malignancy, but at least 5 years since any evidence of disease will be allowed to enroll. Patients with late relapses. For high-dose cycle 2, the patient should not have evidence of progressive disease on imaging or have rapidly rising serum tumor markers following high-dose cycle 1. Serious infections (G>2 NCI-CTC v.4.0). Serum positivity for either HBV, HCV, HIV, CMV. |
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E.5 End points |
E.5.1 | Primary end point(s) |
2-years Progression-free survival. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |