HNSCCNCT05831917
MRI - Guided Adaptive RadioTHerapy for Dysphagia in Head and Neck Cancer
A study testing Radiotherapy in people with HNSCC, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HNSCC
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
Yangkun Luo, 13518161979, 621199521@qq.com
About this study
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.
- Conditions
- HNSCC
- Being tested
- Radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing Difficulty
Swallowing Difficulty will be assessed by MDADI swallowing difficulty score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start17 Jan 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yangkun Luo, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831917
- Sponsor's protocol ID
- SCCHEC-02-2023-017
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI - Guided Adaptive RadioTHerapy for Dysphagia in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05831917
- Acronym / sponsor ID
- SCCHEC-02-2023-017
- Conditions
- HNSCC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy: 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. | Radiation | Treatment Group |
Primary outcome
Swallowing Difficulty
Time frame: 12 months
Swallowing Difficulty will be assessed by MDADI swallowing difficulty score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
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RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with HNSCC, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yangkun Luo (13518161979, 621199521@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing Difficulty (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.