search
Back to results

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

Primary Purpose

HNSCC

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Sichuan Cancer Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HNSCC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-70 years old; I-IVb stage oral cancer, hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer confirmed by histopathology or cytology (AJCC 8th edition); Receiving radical synchronous radiotherapy and chemotherapy; According to the RECIST version 1.1 evaluation criteria, at least one measurable lesion is present; ECOG PS score 0-1; 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; Having sufficient cognitive ability to complete the questionnaire survey; Able to understand and willing to sign a written informed consent form. Exclusion Criteria: There is evidence of swallowing dysfunction (unrelated to HNSCC); Patients who have previously received radiotherapy for the head and neck region; Recurrent or metastatic patients; Involvement of posterior pharyngeal wall, posterior ring, and posterior pharyngeal lymph nodes; Previous tumor resection surgery or major head and neck surgery (excluding biopsy/tonsillectomy); Previous tracheotomy; Participated in other interventional clinical trials within 30 days prior to screening; Individuals with a history of other malignant tumors (excluding cured skin basal cell carcinoma) There are concurrent diseases with poor control (such as heart failure, severe lung disease, severe liver disease, mental illness, etc.); Individuals who are allergic to the use of drugs or their components in this protocol; 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; Researchers believe that it is not suitable to participate in this study; Those who are unwilling to participate in this study or unable to sign an informed consent form;

Sites / Locations

  • Sichuan Cancer Hospital and Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

Swallowing Difficulty
Swallowing Difficulty will be assessed by MDADI swallowing difficulty score

Secondary Outcome Measures

Full Information

First Posted
April 16, 2023
Last Updated
April 16, 2023
Sponsor
Sichuan Cancer Hospital and Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05831917
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HNSCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Swallowing Difficulty
Description
Swallowing Difficulty will be assessed by MDADI swallowing difficulty score
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years old; I-IVb stage oral cancer, hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer confirmed by histopathology or cytology (AJCC 8th edition); Receiving radical synchronous radiotherapy and chemotherapy; According to the RECIST version 1.1 evaluation criteria, at least one measurable lesion is present; ECOG PS score 0-1; 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; Having sufficient cognitive ability to complete the questionnaire survey; Able to understand and willing to sign a written informed consent form. Exclusion Criteria: There is evidence of swallowing dysfunction (unrelated to HNSCC); Patients who have previously received radiotherapy for the head and neck region; Recurrent or metastatic patients; Involvement of posterior pharyngeal wall, posterior ring, and posterior pharyngeal lymph nodes; Previous tumor resection surgery or major head and neck surgery (excluding biopsy/tonsillectomy); Previous tracheotomy; Participated in other interventional clinical trials within 30 days prior to screening; Individuals with a history of other malignant tumors (excluding cured skin basal cell carcinoma) There are concurrent diseases with poor control (such as heart failure, severe lung disease, severe liver disease, mental illness, etc.); Individuals who are allergic to the use of drugs or their components in this protocol; 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; Researchers believe that it is not suitable to participate in this study; Those who are unwilling to participate in this study or unable to sign an informed consent form;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yangkun Luo
Phone
13518161979
Email
621199521@qq.com
Facility Information:
Facility Name
Sichuan Cancer Hospital and Research Institute
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangkun Luo
Phone
13518161979
Email
621199521@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs