E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with LAHNC which will be treated with chemoradiotherapy, as primary treatment or as postoperative treatment |
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E.1.1.1 | Medical condition in easily understood language |
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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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To observe a decrease in number of definite and/or suspected pneumonia after prophylactic treatment with antibiotics during CRT in patients with LAHNC |
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E.2.2 | Secondary objectives of the trial |
To observe a decrease in the number of admissions in the hospital
To observe a decrease in the number of days of admission in the hospital
To measure Quality of life (QoL)
To investigate the effects on mortality
To observe side effects of amoxicillin clavulanic acid
To observe causative agents, including amoxicillin-clavulanic acid resistant, of infections at other sites during follow-up (3.5 months after the end of CRT) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with LAHNC which will be treated with CRT as discussed by a multidisciplinary team (i.e. a head and neck surgeon, a medical oncologist, and a radiation oncologist). This can be CRT as primary treatment or postoperative CRT. Written informed consent
Expected adequacy of follow-up |
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E.4 | Principal exclusion criteria |
Patients with pneumonia within the last 14 days before start of CRT
Patients with other infections within the last 14 days within the last 14 days before start of CRT
Patients with use of maintenance antibiotics Patients with antibiotic treatment within the last 14 days before start of CRT Patients with an allergy on amoxicillin |
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E.5 End points |
E.5.1 | Primary end point(s) |
the number of definite pneumonia and/ or suspected pneumonia. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
every patient visit during the trial en follow up period |
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E.5.2 | Secondary end point(s) |
QoL: measured with the EORTC Quality of Life Quistionnaire C30 (QLQ-C30), the EORTC QLQ Head and Neck Cancer-Specific Module (EORTC H&N35), the PSHHN, the EuroQol-5D(EQ-5D), the EQ- 5D VAS and the SF-36
Number and kind of positive blood cultures
Number of admissions to hospital
Number of days of admission
Mortality due to definite and/or suspected pneumonia
Mucositis grade according to CTCAE v.4.0 and duration
Side effects of amoxicillin/clavulanic acid
Numbers and causative agents of infections at other sites during follow up (3.5 months after the end of CRT) including amoxicillin-clavulanic acid resistant strains |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
lpo: after duration of this trail inc. 1 year follow up: |
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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 | Yes |
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) | Yes |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
in the experimental arm amoxicillin/clavulanic acid suspension 625 mg tid is added as prophylactic t |
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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 | 5 |
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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |