Patient reported outcomes in term of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced head and neck cancer patients treated with definitive chemo-radiotherapy

Phase 1

Recruiting

• Conditions: oropharyngal cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506258-19-00
• Lead Sponsor: Institut Jules Bordet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Age = 18 years old, 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 the principal investigator upon screening), ECOG performance status = 2, Female and Male, Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx and nasopharyngeal carcinoma, Candidate for curative intent radiotherapy and systemic treatment, No prior or current anticancer treatment for the HNC(e.g. neo-adjuvant chemotherapy, surgery), Diagnosis biopsy results available at the time of screening, HPV/p 16 testing results available at the time of screening for oropharyngeal carcinoma, Serum pregnancy test (for subjects of childbearing potential) negative within 7 days prior to the 1st CCRT administration.

Exclusion Criteria

Severe malnutrition according to the Global Leadership Initiative on Malnutrition (GLIM) criteria, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified