E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with squamous cell carcinoma of the head and neck |
Patienter med planocellulær hoved-halskarcinom |
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E.1.1.1 | Medical condition in easily understood language |
Cancer in head and neck |
Kræft i hoved-halsregionen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 show whether a hypoxic gene profile can classify patients that will have no effect of hypoxic modification with nimorazole during radiotherapy |
At eftervise, hvorvidt hypoxi gen-profilen kan udpege patienter som skønnes ikke at have gavn af hypoxisk modifikation med nimorazol under strålebehandling |
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E.2.2 | Secondary objectives of the trial |
To show reduced weight loss, reduced use of tube feeding and reduced patient reported nausea under radiotherapy of the group, randomised to not receiving nimorazole in comparison to those receiving nimorazole |
At vise reduceret vægttab, reduceret brug af sonde og reduceret patientrapporteret kvalmebelastning under strålebehandlingen hos gruppen, der randomiseres til ikke at få nimorazol sammenlignet med de, som får nimorazol.
At registrere compliance til nimorazol. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with HNSCC tumors where, in accordance with DAHANCA’s guidelines, hypoxic modification with nimorazole under primary radiotherapy is indicated. • In addition; a) No concurrent or earlier malignant diseases that can affect the treatment, evaluation and outcome of the actual disease b) Informed consent in accordance with regulations c) Radiotherapy planned to start within 3 weeks from inclusion d) Hypoxic status from gene profile testing must be available no later than by the initiation of radiotherapy.
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Patienter med planocellulære hoved-hals karcinomer, hvor der i henhold til DAHANCA’s retningslinjer er indikation for hypoxisk modifikation med nimorazol under den primære strålebehandling. Herudover: a) Ingen samtidige eller tidligere maligne sygdomme, som kan påvirke behandling, evaluering og udfald af den aktuelle sygdom. b) Informeret samtykke i henhold til lovgivning. c) Strålebehandling planlagt til at starte inden 3 uger fra inklusion. d) Hypoxisk status ved gen-profil skal foreligge senest ved start af strålebehandling.
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Locoregional control after radiotherapy (not including possible salvage treatment).
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Loko-regional tumorkontrol efter stråleterapi (ikke inkluderende evt. salvage behandling).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2-3 months after finalised radiotherapy |
2-3 måneder efter afsluttet stråleterapi |
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E.5.2 | Secondary end point(s) |
Local control (T-site), regional control (N-site), distant metastases, locoregional control after salvage treatment, overall survival (survival, disease- free survival, disease-specific survival), acute or late morbidity |
lokal kontrol (T-site), regional kontrol (N-site), fjernmetastaser, lokoregional kontrol efter salvage, samlet overlevelse (overlevelse, sygdomsfri overlevelse, sygdoms-specifik overlevelse), akut og sen morbiditet. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2-3 months after finalised radiotherapy |
2-3 måneder efter afsluttet stråleterapi |
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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 | No |
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 | No |
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 | 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.8.3 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |