E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy voluntaries are not included in the study |
la sperimentazione non avverra' su pazienti sani |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039022 |
E.1.2 | Term | Rhabdomyosarcoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 investigate the role of doxorubicin dose intensity and maintenance chemotherapy in patients included in the High Risk Group (randomised trial) |
investigare il ruolo della Doxorubicina dose-intensity e della chemioterapia di mantenimento nei pazienti inclusi nel gruppo ad alto rischio (studio randomizzato) |
|
E.2.2 | Secondary objectives of the trial |
to give an homogeneous local and systemic treatment Europe-wide according to the risk of local and metastatic relapse in patients categorized in Low, Standard and Very High risk Groups (observational study) |
somministrare un trattamento locale e sistemico omogeneo a livello europeo in base al rischio di ricaduta locale e metastatica in pazienti classificati a basso,intermedio e rischio molto alto |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
patients with: a)age <21 years; b)pathologically confirmed rhabdomyosarcoma; c) no evidence of metastatic disease; d) previously untreated except for primary surgery. |
pazienti di eta' inferiore ai 21 anni con diagnosi di rabdomiosarcoma localizzato istopatologicamente confermato, precedentemente non trattati ne' con CT ne' con RT. |
|
E.4 | Principal exclusion criteria |
patients with a)age > 21 years; b)metastatic disease; c)previously treated with CT and/or RT; d) pre-existing illness preventing treatment. |
pazienti a)di eta' > 21 anni; b)con metastasi alla diagnosi; c)precedentemente trattati per altre patologie neoplastiche; d) incompatibilita' (es. cardiopatie congenite) con la terapia prevista in questo studio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
3 year-event free survival |
Event free survival a tre anni |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 27 |
E.8.5 | The trial involves multiple Member States | Yes |
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 | No |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |