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 (Jun 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
Treatments studied
Chemotherapy
Other
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.
Frequently asked questions
Is NCT04019548 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require HPV?
Yes, HPV any tested is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages