E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
soft tissue sarcomas |
sarcomi dei tessuti molli |
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E.1.1.1 | Medical condition in easily understood language |
A rare type of cancer that developes in connective tissue. |
Forma di cancro rara che si sviluppa nel tessuto connettivo |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10075333 |
E.1.2 | Term | Soft tissue sarcoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 compare the efficacy, as measured by time to treatment failure, of metronomic cyclophosphamide compared to doxorubicin in elderly patients affected by mSTS. |
Confrontare l’efficacia, misurata come tempo di fallimento del trattamento, di ciclofosfamide metronomica verso doxorubicina in pazienti anziani affetti da mSTS. |
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E.2.2 | Secondary objectives of the trial |
Efficacy, Toxicity profile and to explore other possible predictive or prognostic factors and their interaction with treatment arms.
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Efficacia, profilo di tossicità e identificazione di fattori predittivi o prognostici e la loro interazione con i bracci di trattamento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients may be included in the study only if they meet all the following criteria: 1- Histologically proven diagnosis of soft tissue sarcoma. 2- Advanced unresectable or metastatic soft tissue sarcoma not previously treated with chemotherapy for metastatic disease. 3- At least one measurable lesion according to RECIST1.1 criteria. 4- Availability of a tumor sample 5- Age = 70 years 6- ECOG PS 0-2. 7- Life expectancy of at least 12 weeks. 8- Neutrophils =1.5 x 109/L, Platelets =100 x 109/L, Hgb = 9 g/dl. 9- Normal hepatic, renal anf cardiac function. 10- Male subjects with female partners of childbearing potential must be willing to use adequate contraception. 11- Geriatric assessment by means of G8 screening tool and CRASH score. 12- Written informed consent.
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I pazienti possono essere inclusi nello studio solo se presentano i seguenti criteri: 1- Diagnosi dimostrata istologicamente di sarcoma dei tessuti molli. 2- Sarcoma dei tessuti molli metastatico o avanzato non resecabile non precedentemente trattato con chemioterapia per malattia metastatica. 3- Almeno una lesione misurabile in accordo con i criteri RECIST1.1. 4- Disponibilità di un campione tumorale 5- Età = 70 anni 6- ECOG PS 0-2. 7- Aspettativa di vita di almeno 12 settimane. 8- Neutrofili =1.5 x 109/L, Piastrine =100 x 109/L, Hgb = 9 g/dl. 9- Funzionalità epatica, renale e cardiaca nella norma, 10- Soggetti maschi con partner donne in età fertile, disposti ad utilizzare un'adeguata contraccezione 11- Valutazione geriatrica mediante strumento di screening G8 e punteggio CRASH. 12- Firma del Consenso informato.
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E.4 | Principal exclusion criteria |
Patients will be excluded from the study for any of the following reasons: 1- Previous treatment for metastatic disease. 2- Previous (neo) adjuvant chemotherapy with anthracyclines. 3- Radiotherapy to any site within 4 weeks before the study. 4- Untreated brain metastases or spinal cord compression or primary brain tumors. 5- Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration. 6- Clinically significant cardiovascular disease 7- Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer) 8- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ. 9- Lack of physical integrity of the upper gastrointestinal tract, . 10- Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs. 11- Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies. 12- Sexually active males unwilling to practice contraception
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I pazienti saranno esclusi dallo studio per qualunque delle seguenti ragioni: 1- Precedenti trattamenti per malattia metastatica. 2- Precedente chemioterapia (neo) adiuvante con antracicline. 3- Radioterapia a qualsiasi sito entro 4 settimane prima dello studio. 4- Metastasi cerebrali non trattate o compressione del midollo spinale o tumore primitivo cerebrale. 5- Infezioni attive non controllate o altra malattia concomitante clinicamente rilevante per cui risulta controindicata la somministrazione chemioterapia. 6- Malattia cardiovascolare clinicamente importante. 7- Trattamento con qualunque farmaco sperimentale entro 30 giorni prima dell’arruolamento o che sia trascorso il tempo corrispondente a 2 emi-vite dell’ultimo trattamento sperimentale (a seconda di quale è più lungo) 8- Altre neoplasie coesistenti o neoplasie diagnosticate negli ultimi 5 anni con l'eccezione del carcinoma localizzato a cellule squamose e basale o del carcinoma cervicale in situ. 9- Mancanza di integrità fisica del tratto gastrointestinale superiore, 10- Ipersensibilità nota ai farmaci sperimentali o ad un eccipiente. 11- Necessità di assumere qualsiasi farmaco concomitante, controindicato in associazione ai farmaci sperimentali, in base alle relative schede tecniche. 12- Maschi sessualmente attivi che non accettano di utilizzare metodi contraccettivi validi |
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E.5 End points |
E.5.1 | Primary end point(s) |
time to treatment failure |
tempo di fallimento del trattamento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
every 8 weeks and at progression disease |
ogni 8 settimane ed alla progressione di malattia |
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E.5.2 | Secondary end point(s) |
Progression free survival (PFS) • Overall survival time (OS); • Objective response rate (ORR); ; Toxicity profile; Traslarional research |
Sopravvivenza libera da progressione (PFS) • Tempo di sopravvivenza globale (OS); • Tasso di risposta totale (ORR); ; Profilo di tossicità; Ricerca traslazionale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
every 8 weeks and at PD ; Time from the signing of the IC to 30 days after the end of the treatment, and at PD; At the screening |
ogni 8 settimane e alla PD ; Tempo che intercorre tra la firma del consenso informato e la fine del trattamento, ed alla PD; Allo screening |
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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) | 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 | No |
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 | 13 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |