E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced squamous head and neck cancer |
Cáncer escamoso de cabeza y cuello localmente avanzado |
|
E.1.1.1 | Medical condition in easily understood language |
Tumor of the head and neck region not tributary to surgery |
Tumor de la región de la cabeza y cuello no candidato a cirugía |
|
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 explore the differences in healthy tissue caused by bioradiotherapy and chemoradiotherapy |
Explorar las diferencias en tejido sano causados por bioradioterapia o quimioradioterapia |
|
E.2.2 | Secondary objectives of the trial |
To explore whether there is a relationship between molecular and cellular changes and late toxicity. |
Explorar si hay alguna relación entre cambios moleculares y celulares y toxicidad crónica |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed Informed Consent
2. Age >18 years
3. Histologically confirmed diagnosis of LAHNC.
4. Candidate to radical treatment with chemoradiotherapy or biochemotherapy
5. Ability to understand the purpose and procedures associated to the study, to understand the language in which the information sheet is given, and to give informed consent after instructed about possible complications derived from the study procedures. |
1. Firmar consentimiento informado 2. Edad más de 18 años 3. Diagnostico de cancer de cabeza y cuello confirmado histológicamente 4.Candidato a tratamiento radical con bioradioterapia o quimioradioterapia 5. Capacidad para entender los procedimientos asociados al estudio y la hoja de información |
|
E.4 | Principal exclusion criteria |
1. Patients with LAHNC who are candidates for surgery as radical treatment.
2. Any medical condition that makes the patient unfit to receive radiotherapy, chemotherapy or treatment with cetuximab according to the corresponding group.
3. Any inflammatory skin condition
4. Any known pathology that might interfere with the test results (e.g rheumatoid arthritis, Systemic Lupus Erythematosis, arachnodactyly, dermatomyositis, etc)
5. Any medical condition that increases the risk of complication related to a skin biopsy (e.g. severe skin diseases, anticoagulant therapy)
6. Any social or geographic situation which might interfere with the patient?s ability to attend follow-up visits. |
1. Pacientes candidatos a cirugía para su tumor de cabeza y cuello 2. Contraindicación de quimioterapia, radioterapia o cetuximab 3. Enfermedades inflamatorias de la piel 4. Cualquier comorbilidad que aumente el riesgo de complicaciones asociadas a una biopsia cutánea 5. Situación social o geográfica que interfiera con la capacidad del paciente para atender al seguimiento |
|
E.5 End points |
E.5.1 | Primary end point(s) |
(1)mean value of microvessel density (2) percentage of CD163 positive cells of the total infiltrating cells in selected areas (3) Proportion of myofibroblasts compared to normal fibroblasts (4) fibrosis following a semiquantitative 0-4 scale |
1. media de densidad de microvasos 2. porcentaje de CD163 positivos del total de células infiltrantes en áreas seleccionadas 3. proporción de miofibroblastos comparado con fibroblastos normales 4. fibrosis mediante una escala del 0-4 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Two months afer last dose of radiotherapy |
Dos meses después de la última dosis de radioterapia |
|
E.5.2 | Secondary end point(s) |
Quality of Life by QLQ-C30 and the QLQ-H&N35 questionnaires |
Calidad de vida con los cuestionarios QLQ-C30 y QLQ-H&N35 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
One year after the last radiotherapy dose |
Un año después de la última dosis de 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 | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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.8.5 | 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
|
LVLS |
Última visita del último paciente |
|
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 | 30 |
E.8.9.1 | In the Member State concerned days | |