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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation, Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
CHU Saint Pierre
NOT_YET_RECRUITING
Brussels
Institut Jules Bordet
RECRUITING
Brussels
Time Frame
Start Date: 2019-12-16
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 110
Treatments
Experimental: Prophylactic PEG
Prophylactic PEG tube will be placed before the start of the study treatment (CRT). The enteral nutrition will start following the assessment by the clinical dietitian in order to complete the current oral consumption according to the estimated energy needs (on the basis of 30 to 35 kcal / kg adapted and 1.2 to 1.5 g / prot./ kg.BW) with an increase as needed during the treatment.
Experimental: Reactive PEG
Reactive PEG tube will be placed and enteral nutrition initiated, during the study treatment period in case of decrease of oral intake less than 2/3 of estimated energy requirements (based on 30-35 kcal / adapted kg .BW and 1.2 - 1.5 g/prot./adapted kg. BW) for a period of or anticipated to be, greater than 7 days or weight loss ≥ 5% from pre-treatment baseline).
Related Therapeutic Areas
Sponsors
Leads: Jules Bordet Institute

This content was sourced from clinicaltrials.gov

Similar Clinical Trials