RecruitingPhase 3NCT04019548

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

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

Sponsor

Jules Bordet Institute

Enrollment

110 participants

Start Date

Dec 16, 2019

Study Type

INTERVENTIONAL

Conditions

Oropharyngeal Cancer

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking swallowing function and quality of life over time in patients with throat cancer (oropharyngeal squamous cell carcinoma) who receive combined chemotherapy and radiation therapy. The aim is to understand how treatment affects the ability to swallow and develop strategies to minimize this side effect. **You may be eligible if...** - You are 18 or older - You have a new, confirmed diagnosis of oropharyngeal (throat) squamous cell carcinoma - You are receiving curative-intent chemoradiation (combined chemotherapy and radiation) - You have not had any prior anticancer treatment for this cancer - Women of childbearing potential must have a negative pregnancy test and agree to use contraception **You may NOT be eligible if...** - You have previously received surgery, chemotherapy, or radiation for this cancer - You are pregnant - Your general health is too poor to receive curative treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPercutaneous Endoscopic Gastrotomy tube placement

placement of the PEG tube depends on arm

DRUGCisplatin 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

RADIATIONRadiotherapy

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.