MRI-guided adaptive radiotherapy for swallowing issues in head and neck cancer

MRI - Guided Adaptive RadioTHerapy for Dysphagia in Head and Neck Cancer

This study is testing a new way of giving radiation therapy for head and neck cancer that uses MRI technology to better target tumors and reduce side effects, especially for patients who have trouble swallowing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sichuan Cancer Hospital and Research Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05831917 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of a hybrid machine that combines a linear accelerator with low-field MRI to enhance the precision of radiotherapy for patients with head and neck squamous cell carcinoma (HNSCC). The approach allows for better visualization of tumors and surrounding critical structures during treatment, enabling adjustments to target volumes based on changes in patient anatomy and weight. By adapting treatment daily, the goal is to minimize radiation exposure to healthy tissues while effectively targeting the cancer. This innovative method aims to improve treatment outcomes for patients suffering from dysphagia due to their cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with stage I-IVb head and neck cancers who are receiving radical radiotherapy and chemotherapy.

Not a fit: Patients with early-stage head and neck cancers or those not undergoing concurrent chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve swallowing function and overall quality of life for patients undergoing treatment for head and neck cancer.

How similar studies have performed: While the use of MRI-guided radiotherapy is a relatively novel approach, similar studies have shown promising results in improving treatment precision and patient outcomes.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70 years old;
2. I-IVb stage oral cancer, hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer confirmed by histopathology or cytology (AJCC 8th edition);
3. Receiving radical synchronous radiotherapy and chemotherapy;
4. According to the RECIST version 1.1 evaluation criteria, at least one measurable lesion is present;
5. ECOG PS score 0-1;
6. Hematology indicators are basically normal: white blood cell count ≥ 4 × 109/L； Absolute neutrophil count ≥ 1.5 × 109/L； Platelets ≥ 100 × 109/L； Hemoglobin ≥ 90g/L; Kidney function is basically normal: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl)\>60 mL/min (using Cockcroft Fault formula): Female CrCl=(140 age) × Body weight (kg) × 0.85 / (72 × Scr mg/dl)； Male CrCl=(140 age) × Body weight (kg) × 1.00 / (72 × Scr mg/dl) Liver function is basically normal: serum total bilirubin ≤ 1.5 × ULN； Cereal grass transaminase (AST) ≤ 2.5 × ULN； Glutamate transaminase (ALT) ≤ 2.5 × ULN；
7. Having sufficient cognitive ability to complete the questionnaire survey;
8. Able to understand and willing to sign a written informed consent form.

Exclusion Criteria:

1. There is evidence of swallowing dysfunction (unrelated to HNSCC);
2. Patients who have previously received radiotherapy for the head and neck region;
3. Recurrent or metastatic patients;
4. Involvement of posterior pharyngeal wall, posterior ring, and posterior pharyngeal lymph nodes;
5. Previous tumor resection surgery or major head and neck surgery (excluding biopsy/tonsillectomy);
6. Previous tracheotomy;
7. Participated in other interventional clinical trials within 30 days prior to screening;
8. Individuals with a history of other malignant tumors (excluding cured skin basal cell carcinoma)
9. There are concurrent diseases with poor control (such as heart failure, severe lung disease, severe liver disease, mental illness, etc.);
10. Individuals who are allergic to the use of drugs or their components in this protocol;
11. Pregnant (confirmed by blood or urine HCG testing) or lactating women, or subjects of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment;
12. Researchers believe that it is not suitable to participate in this study;
13. Those who are unwilling to participate in this study or unable to sign an informed consent form;

Where this trial is running

Chengdu, Sichuan

• Sichuan Cancer Hospital and Research Institute — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Yangkun Luo

Conditions HNSCC