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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJules Bordet Institute

About this trial

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 criteria

Qualifiers

Age ≥ 18 years old

ECOG performance status ≤ 2

Female and Male

Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx

Disqualifiers

Severe malnutrition

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)

Trial design

Treatments tested in this trial

  • Percutaneous Endoscopic Gastrotomy tube placement
  • Cisplatin injection
  • Radiotherapy

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators