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RECRUITING
NCT04019548
PHASE3

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

Sponsor: Jules Bordet Institute

View on ClinicalTrials.gov

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

Interventions

DEVICE

Percutaneous Endoscopic Gastrotomy tube placement

placement of the PEG tube depends on arm

DRUG

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

RADIATION

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