Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by… (NCT04019548) | Clinical Trial Compass
RecruitingPhase 3
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
Belgium110 participantsStarted 2019-12-16
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old
✓. ECOG performance status ≤ 2
✓. Female and Male
✓. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx
✓. Candidate for curative intent radiotherapy and systemic treatment
✓. No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)
✓. Diagnosis biopsy results
✓. HPV/p 16 testing results
Exclusion criteria
✕. Severe malnutrition
✕. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE\_v.5)
✕. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
✕. Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin;
What they're measuring
1
global M.D. Anderson Dysphagia Inventory score at 6 months after end of treatment.