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

Recruiting now · Phase 3

Conditions studied: Oropharyngeal Cancer

In brief

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).

Key facts

Study ID

NCT04019548

Run by

Jules Bordet Institute

People needed

110

Starts

2019-12-16

Expected to finish

2030-05-01

Last updated by the study team

2023-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Severe malnutrition
• Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE_v.5)
• Distant metastasis
• Serious coagulation disorders (INR>1.5, PTT>50s, platelets <50000/mm3)
• 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;
• Pregnant and/or lactating women.
• Known hypersensitivity to the study drug (cisplatin) or excipients.

Where it is running

• Institut Jules Bordet — Brussels, Belgium (enrolling)
• CHU Saint Pierre — Brussels, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.