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

Recruiting Phase 3 Interventional Study
Oropharyngeal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Other
Participants needed
110 (estimated)
Sponsor
Jules Bordet Institute · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old 2. ECOG performance status ≤ 2 3. Female and Male 4. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx 5. Candidate for curative intent radiotherapy and systemic treatment 6. No prior or current anticancer treatment…
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