Evaluating swallowing function and quality of life in patients with oropharyngeal cancer after treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial investigates the swallowing function and quality of life in patients diagnosed with oropharyngeal cancer who are undergoing chemoradiotherapy. Participants are randomly assigned to receive either prophylactic or reactive placement of a percutaneous endoscopic gastrostomy (PEG) tube to support nutrition during treatment. All subjects will receive a standard cisplatin chemotherapy regimen alongside intensity-modulated radiotherapy. The study aims to assess the impact of these interventions on patients' swallowing abilities and overall quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institut Jules Bordet
  Brussels, Belgium Recruiting
• CHU Saint Pierre
  Brussels, Belgium Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Selective dose reduction of neck radiation in HPV-associated oropharyngeal cancer

  This trial tests whether lowering radiation doses to certain neck lymph nodes or gross disease areas is safe and can reduce side effects for adults with HPV-related oropharyngeal cancer.

  Recruiting at 4 sites Phase 2 University of Maryland, Baltimore · Baltimore, Maryland and 3 other locations · NCT07418034

• Toripalimab plus standard treatment for HPV-positive throat cancer

  This trial tests whether adding toripalimab to chemotherapy followed by surgery or lower-dose radiation can help adults with HPV16-positive, locoregionally advanced oropharyngeal (throat) cancer.

  Recruiting Phase 2 University of Chicago · Chicago, Illinois · NCT07290621

• Neoadjuvant chemoimmunotherapy with PD-1 blockade to reduce surgery for advanced head and neck cancer

  This approach will try a short course of chemotherapy plus the PD-1 drug toripalimab before standard treatment for people with advanced head and neck cancers to shrink tumors and allow less extensive surgery or radiation.

  Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT07209189

• Lidocaine injection before surgery for oropharyngeal cancer

  This study tests if giving a lidocaine injection before surgery can help improve outcomes for patients with oropharyngeal cancer.

  Recruiting Phase 1 Abramson Cancer Center at Penn Medicine · Philadelphia, Pennsylvania · NCT06747390

• Image-guided proton therapy for advanced head and neck cancer

  This study is testing a new way to use proton therapy combined with chemotherapy to see if it can safely deliver a higher dose to treat advanced head and neck cancer while protecting healthy tissue.

  Recruiting Phase 1 University Medical Center Groningen · Groningen · NCT06446713

• Using circulating tumor DNA to tailor post-surgery treatment for HPV-related throat cancer

  This study is testing if adjusting cancer treatment based on blood tests for HPV DNA can help people with throat cancer after surgery feel better and improve their outcomes.

  Recruiting at 4 sites Phase 2 Cedars-Sinai Medical Center · Beverly Hills, California and 3 other locations · NCT06445114

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.