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

Summary

Participation Requirements

Description

Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer. Study is composed by 2 arms of subjects (male or female): prophylactic or reactive percutaneous endoscopic gastrostomy tube placement. The arm will be allocated by randomisation (1:1). ...

Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer. Study is composed by 2 arms of subjects (male or female): prophylactic or reactive percutaneous endoscopic gastrostomy tube placement. The arm will be allocated by randomisation (1:1). Prophylactic PEG (pPEG): 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. Reactive PEG (rPEG): 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). All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT). Cisplatin: Two therapeutic regimens are allowed: Days 1 and 22: cisplatin 100mg/m2 IV Days 1,8,15,22,29 and 39: weekly cisplatin 40mg/m2 IV Radiotherapy: The median dose prescription will be 32 x 2.16 Gy to the high risk PTV and 32 x 1.75 Gy to the elective PTV. Medical device: The medical device used in this trial is a percutaneous endoscopic gastrostomy tube with the CE label: CE0120. The medical device is used in the indication of the notice. The estimated number of subjects to screen is 121 patients for an estimated number of 110 patients randomised for 100 evaluable patients. The end of study will be declared when all the following criteria will have been met: The study ends after last visit of the last patient remaining in the study. The trial is mature for the analysis of the endpoints as defined in the protocol, if the trial reaches its endpoints. The database has been fully cleaned and frozen for all analyses.

Tracking Information