Compares feeding tube timing in people with throat cancer receiving chemoradiotherapy
Compares early and later feeding tube placement in adults with advanced oropharyngeal cancer.
Plain-language title generated from the registry record
Registry title: Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
Key facts
- Where
- Brussels, BelgiumSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed squamous cell cancer of the oropharynx who will have cisplatin chemotherapy together with radiotherapy.
- Age
- 18 years or older.
- Sex
- Women and men can join.
- Disease stage
- Newly diagnosed squamous cell carcinoma of the oropharynx, no distant metastasis. ECOG performance status of 2 or lower. Able to have treatment meant to remove all of the disease with radiotherapy and systemic treatment.
- Earlier treatment
- No earlier or current anticancer treatment for this head and neck cancer, such as chemotherapy before the main treatment or surgery.
- Biomarker or test result
- Biopsy results and HPV/p16 test results must be available.
Main reasons for not taking part
- Severe malnutrition
- Swallowing problems needing a liquid or puree diet (grade 2 or higher)
- Distant metastasis
- Serious blood clotting disorders
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Where in Belgium
- CHU Saint-PierreBrussels, BelgiumContact: Petra BoegnerNot yet recruiting
- Institut Jules BordetBrussels, BelgiumContact: Tatiana DraganTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jules Bordet Institute
- Trial code
- NCT04019548
- Record updated
- 10 May 2023
- Original description
Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer.Read full original descriptionShow less
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
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).
Inclusion: 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; Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration; Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin; Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin; Adequate bone marrow function as defined below:; Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L; Hemoglobin ≥ 9 g/dL; Platelets ≥100000/µL or 100x109/L; Adequate liver function as defined below:; Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome < 3 x UNL is allowed; AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN; Adequate renal function as defined below:; Creatinine ≤ 1.5 x UNL and creatinine clearance > 60 mL/min; Peripheral neuropathy ≤ grade 1; Hear impaired ≤ grade 1; Completion of all necessary screening procedures within 15 days prior to randomisation; Signed Informed Consent form (ICF) obtained prior to any study related procedure; Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening.
Exclusion: 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; 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; Known hypersensitivity to the study drug (cisplatin) or excipients; Serious coagulation disorders (INR>1.5, PTT>50s, platelets <50000/mm3); Severe malnutrition; Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE_v.5); Distant metastasis; Pregnant and/or lactating women.