Dual-energy and perfusion CT for predicting response to chemo-radiotherapy in head and neck cancer: an exploratory study.
Benjamin Van Honacker, Yolène Lefebvre, Marianne Paesmans...
https://pubmed.ncbi.nlm.nih.gov/42164114Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID04019548
Patient Reported Outcomes on Swallowing and Quality of Life After Prophylactic Versus Reactive PEG Tube Placement in Advanced Oropharyngeal Cancer Patients Receiving Chemo-radiotherapy
Led by Jules Bordet Institute · Updated on 2023-05-10
110
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating swallowing function and quality of life in patients with oropharyngeal cancer treated with chemo-radiotherapy in this open-label, randomized phase III study. The study compares two approaches for placing a percutaneous endoscopic gastrostomy (PEG) tube: prophylactic placement before treatment versus reactive placement during treatment if nutritional intake decreases significantly. All participants will receive standard cisplatin chemotherapy combined with intensity modulated radiotherapy (IMRT). Participants are randomly assigned to one of two groups. The first group receives a prophylactic PEG tube before starting chemoradiotherapy, with enteral nutrition guided by a dietitian to meet energy and protein needs. The second group receives a reactive PEG tube if oral intake falls below two-thirds of estimated energy requirements for more than seven days or if weight loss exceeds 5% from baseline. Chemotherapy involves cisplatin given either as two doses on days 1 and 22 or weekly doses on days 1, 8, 15, 22, 29, and 36. Radiotherapy uses a simultaneous integrated boost IMRT with specific dose prescriptions to the tumor and elective areas. Participants will be monitored through multiple assessments including swallowing function measured by the M.D. Anderson Dysphagia Inventory at six months post-treatment, quality of life evaluations at baseline and various points up to 24 months, and treatment-related toxicities throughout the study. Clinical tumor response and longer-term outcomes will be assessed at 3, 12, and 36 months after treatment. Nutritional status, tobacco use, HPV status, and cost-effectiveness of the treatment strategies will also be evaluated. The total study duration includes screening, treatment, and extended follow-up periods to fully capture patient outcomes.
CONDITIONS
Brief Title
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Male or female
- Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx
- Candidate for curative radiotherapy and systemic treatment
- No prior or current anticancer treatment for head and neck squamous cell carcinoma
- Available diagnosis biopsy results
- Available HPV/p16 testing results
- Negative serum test for subjects of childbearing potential within 7 days before first chemo-radiotherapy
- Women of childbearing potential agree to use highly effective contraception during study and 6 months after last cisplatin dose
- Men with childbearing potential partners agree to use condoms during study and 6 months after last cisplatin dose
- Adequate bone marrow function (ANC ≥ 1500/µL; hemoglobin ≥ 9 g/dL; platelets ≥ 100000/µL)
- Adequate liver function (bilirubin ≤ 1.5 x ULN or < 3 x ULN if Gilbert's syndrome; AST/ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN)
- Adequate renal function (creatinine ≤ 1.5 x ULN; creatinine clearance > 60 mL/min)
- Peripheral neuropathy grade 1 or less
- Hearing impairment grade 1 or less
- Completion of all screening within 15 days prior to randomization
- Signed informed consent form
- Ability to understand and complete questionnaires as judged by investigator
You will not qualify if you...
- Severe malnutrition
- Dysphagia requiring liquid or puree diet (grade 2 or higher)
- Presence of distant metastasis
- Serious coagulation disorders (INR > 1.5, PTT > 50 seconds, platelets < 50000/mm3)
- Significant uncontrolled medical, neuro-psychiatric, or surgical condition
- Other malignancies within 3 years prior to study entry except certain cured or incidental cancers
- Pregnant or lactating women
- Known hypersensitivity to cisplatin or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 7 weeks
Participants receive chemo-radiotherapy with cisplatin and radiotherapy. Prophylactic PEG tube placement occurs before treatment start for some participants, while others may receive reactive PEG tube placement during treatment if needed based on oral intake or weight loss.
Multiple visits during treatment including chemotherapy and radiotherapy sessions
Follow-up
Duration - Up to 36 months after end of treatment
Participants are monitored for swallowing function, quality of life, treatment-related toxicities, nutritional status, tumor response, and overall outcomes after treatment completion.
Visits at 1, 3, 6, 12, 24, and 36 months after treatment end
Trial Site Locations
Total: 2 locations
1
CHU Saint Pierre
Brussels, Belgium, 1000
Not Yet Recruiting
2
Institut Jules Bordet
Brussels, Belgium, 1000
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Patient-reported outcomes in terms 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: Swall PEG study.
Tatiana Dragan, André Van Gossum, Frederic Duprez...
https://pubmed.ncbi.nlm.nih.gov/36539781