drugset / Trial / NCT04019548

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

NCT04019548 ↗

Phase 3 Recruiting 110 enrolled Jules Bordet Institute
RandomizedParallel-groupOpen-labelOther

Summary

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).

Timeline

Start
2019-12-16
Primary completion
2027-11-01
Completion
2030-05-01

Drugs

EvaluationDrugModalityDoseRoute
Background Cisplatin Other / unclassified 40 mg/m2 Intravenous
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous

Indications