NCT04019548 Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
| NCT ID | NCT04019548 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jules Bordet Institute |
| Condition | Oropharyngeal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2019-12-16 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 110 participants in total. It began in 2019-12-16 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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 for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery) 7. Diagnosis biopsy results 8. HPV/p 16 testing results 9. Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration. 10. 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. 11. 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. 12. 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 13. 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 14. Adequate renal function as defined below: * Creatinine ≤ 1.5 x UNL and creatinine clearance \> 60 mL/min 15. Peripheral neuropathy ≤ grade 1 16. Hear impaired ≤ grade 1 17. Completion of all necessary screening procedures within 15 days prior to randomisation. 18. Signed Informed Consent form (ICF) obtained prior to any study related procedure. 19. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening Exclusion Criteria: 1. Severe malnutrition 2. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE\_v.5) 3. Distant metastasis 4. Serious coagulation disorders (INR\>1.5, PTT\>50s, platelets \<50000/mm3) 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. 6. 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; 7. Pregnant and/or lactating women. 8. Known hypersensitivity to the study drug (cisplatin) or excipients.
Frequently Asked Questions
Who can join the NCT04019548 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oropharyngeal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04019548 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 110 participants.
Is NCT04019548 currently recruiting?
Yes, NCT04019548 is actively recruiting participants. Visit ClinicalTrials.gov or contact Jules Bordet Institute to inquire about joining.
Where is the NCT04019548 trial being conducted?
This trial is being conducted at Brussels, Belgium, Brussels, Belgium.
Who is sponsoring the NCT04019548 clinical trial?
NCT04019548 is sponsored by Jules Bordet Institute. The trial plans to enroll 110 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.