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Patient reported outcomes in term of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced head and neck cancer patients treated with definitive chemo-radiotherapy
EU CTIS ID: 2023-506258-19-00
What this study is testing
The main objective of this trial is to assess and compare the subjects reported outcomes measurements in term of swallowing (MD Anderson Dysphagia Inventory (MDADI)) 6 months after end of chemoradiotherapy treatment in subjects randomized to either the prophylactic PEG tube group or the reactive PEG tube group.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years old
- 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
You likely can't join if
- Severe malnutrition according to the Global Leadership Initiative on Malnutrition (GLIM) criteria
- 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
See the full eligibility criteria
- Age ≥ 18 years old
- 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 the principal investigator upon screening)
- ECOG performance status ≤ 2
- Female and Male
- Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx and nasopharyngeal carcinoma
- Candidate for curative intent radiotherapy and systemic treatment
- No prior or current anticancer treatment for the HNC(e.g. neo-adjuvant chemotherapy, surgery)
- Diagnosis biopsy results available at the time of screening
- HPV/p 16 testing results available at the time of screening for oropharyngeal carcinoma
- Serum pregnancy test (for subjects of childbearing potential) negative within 7 days prior to the 1st CCRT administration.
- Severe malnutrition according to the Global Leadership Initiative on Malnutrition (GLIM) criteria
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.