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Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
Sponsor: Jules Bordet Institute
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2019-12-16
Completion Date
2030-05-01
Last Updated
2023-05-10
Healthy Volunteers
No
Conditions
Interventions
Percutaneous Endoscopic Gastrotomy tube placement
placement of the PEG tube depends on arm
Cisplatin injection
Two therapeutic regimen allowed: * Days 1 and 22 : cisplatin 100mg/m2 IV * Days 1,8,15,22,29,36: weekly cisplatin 40 mg/m2 IV
Radiotherapy
Simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT). The median dose prescription will be 32 x 2.16 Gy to the high risk PTV and 32 x 1.75 Gy to the elective PTV.
Locations (2)
CHU Saint Pierre
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium