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
Jules Bordet Institute
110 participants
Dec 16, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria26
- 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
Exclusion Criteria8
- 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)
- Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
- Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin;
- Pregnant and/or lactating women.
- Known hypersensitivity to the study drug (cisplatin) or excipients.
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Interventions
placement of the PEG tube depends on arm
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
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04019548