Clinical trial NCT05831917: MRI - Guided Adaptive RadioTHerapy for Dysphagia in Head and Neck Cancer
Official title: MRI - Guided Adaptive RadioTHerapy for Dysphagia in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HNSCC
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recently developed hybrid machines (MRidian®-CE approval since 2016), consisting of a linear accelerator and an integrated low-field MRI, could allow better visualization of tumor and organs at risk during patient positioning and daily treatment finally repetitive adaptation of target volumes according to changes in patient weight and tumor anatomy during the radiotherapy course. These procedures would facilitate a high-precision treatment and help reduce dose exposure of critical structures.


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;

Primary outcomes:
measure: Swallowing Difficulty
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
Study officials:
References: