Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy

Inclusion Criteria:

1. Age ≥ 18 years old
2. ECOG performance status ≤ 2
3. Female and Male
4. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of theoropharynx
5. Candidate for curative intent radiotherapy and systemic treatment
6. No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvantchemotherapy, surgery)
7. Diagnosis biopsy results
8. HPV/p 16 testing results
9. Serum test (for subjects of childbearing potential) negative within 7 days prior tothe 1st CRT administration.
10. Women of childbearing potential must agree to use of one highly effective method ofcontraception prior study entry, during the course of the study and at least 6 monthsafter the last administration of cisplatin.
11. Men with childbearing potential partner must agree to use condom during the course ofthis study and for at least 6 months after the last administration of the cisplatin.
12. Adequate bone marrow function as defined below:

• Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L
• Hemoglobin ≥ 9 g/dL
• Platelets ≥100000/µL or 100x109/L

13. Adequate liver function as defined below:

• Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome < 3 x UNLis allowed
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
• Alkaline phosphatase ≤ 2.5 x ULN

14. Adequate renal function as defined below:

• Creatinine ≤ 1.5 x UNL and creatinine clearance > 60 mL/min

15. Peripheral neuropathy ≤ grade 1
16. Hear impaired ≤ grade 1
17. Completion of all necessary screening procedures within 15 days prior torandomisation.
18. Signed Informed Consent form (ICF) obtained prior to any study related procedure.
19. Ability to understand and complete the questionnaires (language proficiency, cognitivefunctioning) as judged by principal investigator upon screening

Exclusion Criteria:

1. Severe malnutrition
2. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE_v.5)
3. Distant metastasis
4. Serious coagulation disorders (INR>1.5, PTT>50s, platelets <50000/mm3)
5. Subject with a significant medical, neuro-psychiatric, or surgical condition,currently uncontrolled by treatment, which, in the principal investigator's opinion,may interfere with completion of the study.
6. Other malignancies in the 3 years prior to study entry except of surgically curedcarcinoma in situ of the cervix, in situ breast cancer, incidental finding of stageT1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin;
7. Pregnant and/or lactating women.
8. Known hypersensitivity to the study drug (cisplatin) or excipients.