ConditionOropharyngeal Cancer
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 groupsSponsors and collaborators
Source ClinicalTrials.gov