Actively Recruiting
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
Led by Jules Bordet Institute · Updated on 2023-05-10
110
Participants Needed
2
Research Sites
541 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status 2 or less
- Male or female
- 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 head and neck squamous cell carcinoma
- Available diagnosis biopsy results
- Available HPV/p16 testing results
- Negative serum test within 7 days before starting chemoradiotherapy for subjects of childbearing potential
- Women of childbearing potential agree to use one highly effective contraception method before, during, and 6 months after last cisplatin dose
- Men with partners of childbearing potential agree to use condoms during study and for at least 6 months after last cisplatin dose
- Adequate bone marrow function: ANC ≥1500/µL, hemoglobin ≥9 g/dL, platelets ≥100000/µL
- Adequate liver function: bilirubin ≤1.5 x ULN (≤3 x ULN if Gilbert's syndrome), AST/ALT ≤2.5 x ULN, alkaline phosphatase ≤2.5 x ULN
- Adequate renal function: creatinine ≤1.5 x ULN and creatinine clearance >60 mL/min
- Peripheral neuropathy grade 1 or less
- Hearing impairment grade 1 or less
- Completed all screening procedures within 15 days before randomization
- Signed informed consent form
- Ability to understand and complete questionnaires as judged by investigator
You will not qualify if you...
- Severe malnutrition
- Dysphagia requiring liquid or puree texture modified diet (grade 2 or higher)
- Presence of distant metastasis
- Serious coagulation disorders (INR >1.5, PTT >50 seconds, platelets <50000/mm3)
- Significant uncontrolled medical, neuro-psychiatric, or surgical conditions interfering with study completion
- Other malignancies within 3 years prior to study entry except certain cured or incidental cancers
- Pregnant or lactating women
- Known hypersensitivity to cisplatin or its excipients
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CHU Saint Pierre
Brussels, Belgium, 1000
Not Yet Recruiting
2
Institut Jules Bordet
Brussels, Belgium, 1000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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