E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Head and neck cancer |
carcinoma della testa e collo |
|
E.1.1.1 | Medical condition in easily understood language |
Head and neck cancer |
Tumore testa e collo |
|
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 | 20.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10046311 |
E.1.2 | Term | Upper respiratory tract neoplasms |
E.1.2 | System Organ Class | 100000004855 |
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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 |
• Complete control [no vomiting, no rescue treatment, and no signi¿cant nausea (VAS<25mm)] along the period of chemoradiation 4th week - 1 week after RT end (5 weeks altogether) |
Controllo completo (assenza di vomito, nessuna terapia di salvataggio e nessun episodio significativo di nausea (VAS<25mm) lungo tutto il periodo di radiochemoterapia – dalla quarta settimana fino a una settimana dopo il termine della radioterapia (durata totale – 5 settimane) |
|
E.2.2 | Secondary objectives of the trial |
• Incidence of nausea and vomiting • Rescue drugs employed (metoclopramide) • Safety (QTc change, assessment of grade 3-4 AEs) • Compliance with the study drug • QOL (MDASI-HN) • PRO-CTCAE library building in HNC pts • Pharmacokinetics in the first 10 pts enrolled in the coordinating Center • Correlation of mean radiation dose to vomiting center structures with incidence of nausea and vomiting |
• Incidenza di nausea e vomito • Impiego terapia di salvataggio (Metoclopramide) • Sicurezza del trattamento (alterazioni PTc, valutazione di eventi avversi di grado 3 e 4) • Aderenza al trattamento sperimentale • Determinati di qualità della vita (misurati con il questionario MDASI HN) • Punteggi della scala PRO-CTCAE testa e collo • Farmacocinetica nei primi 10 pazienti arruolati nel centro coordinatore • Correlazione tra la dose media irradiata alle strutture del centro del vomito e l’incidenza di nausea e vomito. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and Females aged >= 18 years. 2. Patients affected by head and neck cancer in one of the following subsites: oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinus, salivary gland, skin of the head and neck, unknown primary in head and neck area 3. Naïve to chemotherapy. 4. Patients planned to receive 3 cycles of highly emetogenic treatments with cisplatin in single dose > 70 mg/m2 every 21 days concomitant to IMRT on head and neck 5. Willing and able to understand and sign informed consent and complete the patient diary |
1. Maschi e femmine di età> = 18 anni. 2. Pazienti affetti da tumore della testa e del collo in uno dei seguenti siti secondari: cavità orale, orofaringe, ipofaringe, laringe, rinofaringe, seno paranasale, ghiandola salivare, pelle della testa e del collo 3. Naïve alla chemioterapia. 4. I pazienti candidati a ricevere 3 cicli di trattamenti altamente emetogeni con cisplatino in dose singola> 70 mg / m2 ogni 21 giorni in concomitanza con radioterapia su testa e collo 5. Disponibilità e capacità di comprendere e firmare il consenso informato e completare il diario del paziente |
|
E.4 | Principal exclusion criteria |
1. Scheduled to receive or having received in the past 4 weeks radiation treatment to brain, abdomen or pelvis. 2. Brain metastasis 3. Emesis or significant nausea within 24 hours before first chemotherapy cycle. 4. Known ypersensitivity reaction to GTDS or any components of the product. 5. Planne surgery procedures in the period of the study or within 2 weeks after the study conclusion. 6. Historyof seizures or epilepsy. 7. Active use of cannabinoids. 8. Use of other investigational drugs within 30 days before study entry or during the study. 9. Clinicaly significant findings on physical exam or presence of known clinically significant disease that would interfere with study evaluate. |
1. Paziente candidato a ricevere o che abbia ricevuto nelle ultime 4 settimane trattamento radiante al cervello, all'addome o alla pelvi. 2. Metastasi cerebrali 3. Emesi o nausea significativa entro 24 ore prima del primo ciclo di chemioterapia. 4. Reazione di ipersensibilità nota a GTDS o a qualsiasi componente del prodotto. 5. Procedure di chirurgia nel periodo dello studio o entro 2 settimane dopo la conclusione dello studio. 6. Anamnesi di convulsioni o epilessia. 7. Uso attivo di cannabinoidi. 8. Uso di altri farmaci sperimentali entro 30 giorni prima dell'ingresso nello studio o durante lo studio. 9. Risultati clinici significativi sull'esame fisico o sulla presenza di una malattia clinicamente significativa nota che interferirebbe con la valutazione dello studio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Complete control [no vomiting, no rescue treatment, and no signi¿cant nausea (VAS<25 mm)] along the period of chemoradiation 4th week - 1 week after RT end (5 weeks altogether) |
Controllo completo [nessun vomito, nessun trattamento di salvataggio e nessuna significativa nausea (VAS <25 mm)] durante il periodo di chemioterapia 4a settimana - 1 settimana dopo la fine della RT (5 settimane in tutto) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 week after the end of radiotherapy |
1 settimana dopo il completamento della radioterapia |
|
E.5.2 | Secondary end point(s) |
• Incidence of nausea and vomiting; • Safety (QTc change, grade 3 adverse events); Quality of live (QOL MDASI-HN) |
Incidenza di nausea e vomito; . Sicurezza ( variazioni di QTc ed eventi avversi di grado 3); • Qualità della vita (QOL MDASI-HN) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
during 5 weeks of treatment; during the 5 weeks of treatment up to 1 week after the completion of radiotherapy; during the 5 weeks of treatment up to 1 week after the completion of radiotherapy |
durante le 5 settimane di trattamento fino ad 1 settimana dopo il completamento della radioterapia; durante le 5 settimane di trattamento fino ad 1 settimana dopo il completamento della radioterapia; durante le 5 settimane di trattamento fino ad 1 settimana dopo il completamento della radioterapia |
|
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 | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 18 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |