E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
head and neck squamous cell carcinoma eligible for a curative treatment with radiotherapy and Cetuximab
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carcinoma squamoso del distretto cervico facciale candidati a trattamento curativo con radioterapia e Cetuximab |
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E.1.1.1 | Medical condition in easily understood language |
Patients with head and neck tumor eligible for a curative treatment with radiotherapy and Cetuximab |
Pazienti affetti da tumore del distretto testa collo candidati ad una terapia a scopo curativo con radioterapia e Cetuximab |
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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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060121 |
E.1.2 | Term | Squamous cell carcinoma of head and neck |
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 |
To test the feasibility, in the clinical practice, of a radiation treatment with a time dose modulation |
Valutare la fattibilità nella pratica clinica di un trattamento radiante con modulazione temporale della dose |
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E.2.2 | Secondary objectives of the trial |
-Evaluation of skin toxicity and comparison with literature data -Evaluation of treatment response rate (Overall Response Rate –ORR) and comparison with literature data
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-Valutazione della tossicità cutanea acuta e confronto con i dati storici di letteratura -Valutazione del tasso di risposta al trattamento (Overall Response Rate – ORR) e confronto con i dati storici di letteratura
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Pazienti con diagnosi istologica di carcinoma squamoso dell’orofaringe, laringe ed ipofaringe con indicazione a trattamento con radioterapia e Cetuximab a scopo curativo - Overespressione di EGFR (>50%) - PS (ECOG) ≤2 - Pazienti con età > 18 anni - Consenso informato scritto
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- Patients with an histological diagnosis of squamous cell carcinoma of the oropharynx, larynx and hypopharynx eligible for a curative treatment with radiotherapy and Cetuximab - Overexpression of EGFR (> 50%) - PS (ECOG) ≤2 - Age > 18 years - Written informed consent
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E.4 | Principal exclusion criteria |
- Presence of distant metastasis - Oral cavity and nasopharynx tumor - Skin bolus required - Previous treatments on the head and neck region - Collagen disease or severe comorbidities
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- Presenza di Metastasi a distanza - Neoplasie del cavo orale e del rinofaringe - Necessità di bolus sulla cute - Precedenti trattamenti sul distretto cervico-facciale - Malattie del collagene o gravi malattie sistemiche
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E.5 End points |
E.5.1 | Primary end point(s) |
- To test the feasibility, in the clinical practice, of a radiation treatment with a time dose modulation |
- Valutare la fattibilità nella pratica clinica di un trattamento radiante con modulazione temporale della dose |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-Evaluation of skin toxicity and comparison with literature data -Evaluation of treatment response rate (Overall Response Rate –ORR) and comparison with literature data
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-Valutazione della tossicità cutanea acuta e confronto con i dati storici di letteratura -Valutazione del tasso di risposta al trattamento (Overall Response Rate – ORR) e confronto con i dati storici di letteratura
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | 14 |
E.8.9.1 | In the Member State concerned days | |