E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Head-and-neck cancer (Squamous cell carcinomas) |
Carcinoma squamoso del distretto testa-collo |
|
E.1.1.1 | Medical condition in easily understood language |
Head and neck cancer |
Tumore del distretto testa-collo |
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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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing to chemo-radiotherapy. |
Verificare l’attività di SAMITAL nel ridurre l’incidenza di mucosite severa in pazienti con carcinoma del distretto testa-collo sottoposti a chemio-radioterapia. |
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E.2.2 | Secondary objectives of the trial |
Assess tolerability of SAMITAL and the impact on patients reported outcomes. |
Valutare la tollerabilità di SAMITAL ed il suo impatto sulla qualità di vita e sui sintomi riportati dai pazienti. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Histologically proven squamous cell carcinomas of the head-and-neck; •primary tumor sites eligible: oral cavity, oropharynx, larynx, hypopharynx; •stage III or IV disease without evidence of distant metastases; •patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemoradiotherapy; •age 18-75 years; •Karnofsky Performance Status ≥70; •life expectancy ≥6 months; able to swallow and retain oral medication; •good state of dentation; •patients must be available for treatment and follow-up; •insurance by the patient and/or partner who will use adequate contraception; •signed informed consent |
•Diagnosi istologica di carcinoma squamoso del distretto testa-collo; •Sedi di tumore primario eleggibili: cavità orale, orofaringe, laringe, ipofaringe; •Stadio III o IV di malattia senza evidenza di metastasi a distanza; •Pazienti candidati a chemio-radioterapia concomitante o chemioterapia di induzione seguita da chemio-radioterapia; •Età compresa tra 18 e 75 anni; •Karnofsky Performance Status ≥ 70; •Spettanza di vita ≥ 6 mesi; •Capacità di assumere il farmaco in studio secondo le modalità previste; •Stato di dentizione buono o recentemente sottoposto a bonifica; •Disponibilità di sottoporsi a follow-up; • Assicurazione da parte del paziente e/o partner che verranno utilizzati adeguati metodi contraccettivi; •Consenso informato scritto. |
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E.4 | Principal exclusion criteria |
•Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx; •seroius comorbidities: uncontrolled heart disease, heart failure within 6 months prior to study partecipation, history of serious neurological and/or psychiatric abnormality; •chronic administration of steroids or immunosuppressant; •pregnant female. |
•Precedente irradiazione delle mucose del cavo orale e/o dell’orofaringe, laringe, ipofaringe; •Significative comorbidità: - patologie cardiache non controllate farmacologicamente; - infarto del miocardio nei 6 mesi precedenti la partecipazione allo studio; - anamnesi positiva per gravi disordini neurologici o psichiatrici; •Uso cronico di farmaci steroidi o immunosoppressori; •Donne in gravidanza. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developed at any time during the whole study period. |
Proporzione di soggetti con grado III, IV di mucosite misurata con la WHO mucositis scale, sviluppata in qualsiasi momento, durante tutto il periodo di studio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy. |
Settimanalmente durante la radioterapia, a 4 settimane e a 3 mesi dalla fine della radioterapia |
|
E.5.2 | Secondary end point(s) |
•Incidence of adverse events assessed by NCI-CTCAE version 4.0; •Days of CT-RT treatment interruption and their period suspection; •Use of enteral or parenteral nutritional support; •Weight loss; •Use of analgesic drugs during CT-RT; •Changes of the Karnofsky Performance Status at the 11th week; •Quality of life assessed by EORTC QLQ-C30 and QLQ-H&N35; •Grade of Xerostomia and its trend over time assessed by Xerostomia Questionnaire. |
•Incidenza di eventi avversi valutata con la NCI-CTCAE v.4 ; •Interruzione/i del trattamento chemio-radioterapico e relativa durata in giorni della sospensione; •Ricorso a supporto nutrizionale artificiale enterale o parenterale; •Calo ponderale; •Impiego e categoria dei farmaci analgesici utilizzati durante la chemio-radioterapia; •Modificazione del Karnofsky Performance Status all’undicesima settimana •Qualità della Vita valutata con i questionari EORTC QLQ-C30 e QLQ-H&N35; •Grado di xerostomia e suo andamento temporale valutato con Xerostomia Questionnaire |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy. For the quality of life, at 4th, 7th, 11th and 23rd weeks. |
Settimanalmente durante la radioterapia, a 4 settimane e a 3 mesi dalla fine della radioterapia. Per la qualità della vita, a 4, 7, 11 e 23 settimane. |
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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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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
| 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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 32 |
E.8.9.1 | In the Member State concerned days | 0 |