Study to identify which changes in normal tissue could be related to long term adverse efects of radiotherapy associated to chemotherapy or to treatment with an antibody in patients with tumors of the head and neck regio

Conditions: ocally advanced squamous head and neck cancer
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-003012-21-ES

Lead Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To explore whether there is a relationship between molecular and cellular changes and late toxicity.;Primary end point(s): (1)mean value of microvessel density<br>(2) percentage of CD163 positive cells of the total infiltrating cells in selected areas <br>(3) Proportion of myofibroblasts compared to normal fibroblasts<br>(4) fibrosis following a semiquantitative 0-4 scale;Main Objective: To explore the differences in healthy tissue caused by bioradiotherapy and chemoradiotherapy;Timepoint(s) of evaluation of this end point: Two months afer last dose of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of Life by QLQ-C30 and the QLQ-H&N35 questionnaires;Timepoint(s) of evaluation of this end point: One year after the last radiotherapy dose