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

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.

Study Overview

• Status: Recruiting
• Conditions: HNSCC
• Intervention / Treatment: Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yangkun Luo; Phone Number: 13518161979; Email: 621199521@qq.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital and Research Institute
      • Contact: Yangkun Luo; Phone Number: 13518161979; Email: 621199521@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment Group

Radiation: Radiotherapy; Radiotherapy: All patients were treated with Unity MRI Linac intensity modulated radiation therapy, daily imaging of MRI-IGRT and online target delineation, redesign, and total radiation dose: GTV 70Gy/33f, GTVLN 70Gy/33f, CTV 60Gy/33f, CTVLN 54Gy/33f, 5 days per week. Dose limit: The average dose to the upper, middle, and lower pharyngeal constrictor muscles is ≤ 40-50Gy, with oropharyngeal cancer requiring an average dose to the upper, middle, and lower pharyngeal constrictor muscles to be ≤ 50Gy and ≤ 20Gy; Lower pharyngeal cancer requires an average dose of ≤ 40Gy for the upper and middle pharyngeal constrictor muscles, and ≤ 50Gy for the lower pharyngeal constrictor muscles. chemotherapy: cisplatin 75mg/m2, 21 days per cycle, a total of 3 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing Difficulty	Swallowing Difficulty will be assessed by MDADI swallowing difficulty score	12 months

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: SCCHEC-02-2023-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No