OncoMatch/Clinical Trials/NCT04019548
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
Is NCT04019548 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Percutaneous Endoscopic Gastrotomy tube placement and Cisplatin for oropharyngeal cancer.
Treatment: Percutaneous Endoscopic Gastrotomy tube placement · Cisplatin — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV any tested
HPV/p 16 testing results
Disease stage
Excluded: Stage DISTANT METASTASIS
Distant metastasis [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anticancer treatment
No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500/µL or 1.5x10^9/L; Hemoglobin ≥ 9 g/dL; Platelets ≥100000/µL or 100x10^9/L
Kidney function
Creatinine ≤ 1.5 x ULN and creatinine clearance > 60 mL/min
Liver function
Serum total bilirubin ≤ 1.5 x ULN (Gilbert's syndrome < 3 x ULN allowed); AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN
Adequate bone marrow function as defined below: ANC ≥1500/µL or 1.5x10^9/L; Hemoglobin ≥ 9 g/dL; Platelets ≥100000/µL or 100x10^9/L. Adequate liver function as defined below: Serum total bilirubin ≤ 1.5 x ULN (Gilbert's syndrome < 3 x ULN 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 ULN and creatinine clearance > 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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