Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Behaviors and Mental Disorders

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

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 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).

Percutaneous Endoscopic Gastrotomy tube placement

Two therapeutic regimen allowed:

* Days 1 and 22 : cisplatin 100mg/m2 IV
* Days 1,8,15,22,29,36: weekly cisplatin 40 mg/m2 IV

Cisplatin injection

Simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT). 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.

Radiotherapy

Tatiana Dragan

Petra Boegner

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).

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.

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

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

The M.D.Anderson Dysphagia inventory is a dysphagia-specific quality-of-life questionnaire for patients with H\&N cancer including 20 items divided into 4 subscales emotional (6 questions), functional (5 questions), physical (8 questions) and one global question. Each subscale has a score ranging from 1 to 5 (higher scores represent a better outcome). The mean score of the 20 items will be multiplied by a factor of 20 to obtain a MDADI total score which ranges from 20 (extremely low functioning) to 100 (high functioning). A difference of 8 points in MDADI score is considered as the Minimal Clinically Important Difference for the trial.

Outcome measure: completion of EORTC QLQ-C30 questionnaire

Outcome measure: completion of EORTC QLQ-H\&N43 module questionnaire

Outcome measure: completion of FACT-HN questionnaire

Outcome measure: Incidence, type and severity of all adverse events (AEs) and serious adverse events according to CTCAE version 5.0 ;

Outcome measure:Incidence, type and severity of radiotherapy related AEs also according to Radiation Therapy Oncology Group (RTOG) / European Organisation for Research and treatment of Cancer (EORTC) scores; In the RTOG/EORTC Late Radiation Morbidity Scoring, 0 means an absence of radiation effects and 5 means the effects led to death. The severity of reactions is graded from 1 through 4.

Outcome measure:Severity of oropharyngeal mucositis and swallowing disorders according to Internal consensus scale (ICS);

Outcome measure: Oropharyngeal mucositis according to the oral mucositis weekly questionnaire-Head and Neck cancer (OMWQ-NH) completed by the subject;

Outcome measure: Salivary toxicity according to the xerostomia questionnaire completed by the subject.

Outcome measure: Clinical dietitian assessment including risk screening by Nutritional Risk Screening 2002 (NRS-2002)

Outcome measure: Clinical dietitian assessment using GLIM criteria (Global Leadership Initiative on Malnutrition criteria).

Outcome measure:Tumour response after study treatment measured by DECT and PET-CT

Outcome measure: loco regional control (LRC)

Outcome measure: distant recurrence/distant progression (DR/DP)

Outcome measure: disease-free survival (DFS)

Outcome measure: disease specific survival (DSS)

Outcome measure: Assessment of the smoking consumption

Outcome measure: EuroQol 5D5L Questionnaire

HPV-based prognostic nomogram for oro-pharyngeal carcinoma

prediction tool for swallowing dysfunction, xerostomia, sticky saliva and tube feeding dependence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy	NCT04019548	Oropharyngeal C...	Percutaneous En... Cisplatin injec... Radiotherapy	18 Years -	Jules Bordet Institute
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy	NCT04019548	Oropharyngeal C...	Percutaneous En... Cisplatin injec... Radiotherapy	18 Years -	Jules Bordet Institute

Spots Global Cancer Trial Database for percutaneous endoscopic gastrotomy tube placement