Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy
Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer. Study is composed by 2 arms of subjects: prophylactic or reactive percutaneous endoscopic gastrostomy tube placement. All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).
• Age ≥ 18 years old
• ECOG performance status ≤ 2
• Female and Male
• Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx
• Candidate for curative intent radiotherapy and systemic treatment
• No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)
• Diagnosis biopsy results
• HPV/p 16 testing results
• Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.
⁃ Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.
⁃ Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.
⁃ 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
⁃ Adequate liver function as defined below:
∙ Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \< 3 x UNL is allowed
‣ AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
‣ Alkaline phosphatase ≤ 2.5 x ULN
⁃ Adequate renal function as defined below:
∙ Creatinine ≤ 1.5 x UNL and creatinine clearance \> 60 mL/min
⁃ Peripheral neuropathy ≤ grade 1
⁃ Hear impaired ≤ grade 1
⁃ Completion of all necessary screening procedures within 15 days prior to randomisation.
⁃ Signed Informed Consent form (ICF) obtained prior to any study related procedure.
⁃ Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening