IORT in Local Advanced Laryngocarcinoma

Study Overview
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Brief Summary
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The incidence of laryngeal cancer accounts for about 1   5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of patients. The efficacy, safety and feasibility of intraoperative radiotherapy (IORT) in head and neck cancer has been demonstrated in multiple institutional (3-5) studies to optimize local control. It is still unclear whether IORT can improve the local control and have efficacy, safety and feasibility in clinic. The purpose of this study was to observe the efficacy, safety and feasibility of IORT in local advanced laryngocarcinoma .

Official Title
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Study of Safety and Feasibility With or Without Intraoperative Radiation in Local Advanced Laryngocarcinoma

Conditions
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Laryngeal Neoplasms

Intervention / Treatment
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* Radiation: IORT
* Procedure: surgery
* Radiation: External radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults over the age of 18; radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines); the expected survival time ≥ 3 months; sign informed consent for treatment and research with self-knowledge. Exclusion Criteria: there is distant metastasis; pregnant women; patients with CT/MRI contraindications; the patient fails to receive treatment and/or follow-up as scheduled; bad fluid and organ function decompensation; multiple primary cancers; patients participating in other trials.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with IORT<br> | Radiation: IORT<br>* IORT in surgery of laryngocarcinoma<br>Procedure: surgery<br>* total laryngectomy or hemilaryngectomy<br>Radiation: External radiotherapy<br>* External radiotherapy<br>|
| Active Comparator: without IORT<br> | Procedure: surgery<br>* total laryngectomy or hemilaryngectomy<br>Radiation: External radiotherapy<br>* External radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year local recurrence rate | In this study, no matter whether distant metastases occurred, if there was the presence of any anastomotic or lateral node recurrences, it was defined as local recurrence. Criteria for local recurrence include (1) MRI results suggests local tumor recurrence, (2)Laryngoscopy indicates local tumor recurrence. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year disease free survival | Compare 2-year disease free survival in patients with local advanced laryngocarcinoma treated with or without IORT. Criteria for disease free survival means MRI and laryngoscopy (PET-CT if possible) indicate tumor free. | 2 years | 
| 2-year overall survival | Compare 2-year overall survival in patients with local advanced laryngocarcinoma treated with or without IORT. | 2 years | 
| tissue necrosis | Compare the risk of tissue necrosis as determined visually by the Laryngoscope at 2 years after treatment in patients with local advanced laryngocarcinoma treated with or without IORT. | 2 years | 
| fibrosis | Compare the risk of fibrosis as determined visually by the Laryngoscope at 2 years after treatment in patients with local advanced laryngocarcinoma treated with or without IORT. | 2 years | 
| time of wound healing | Compare the time of wound healing after surgery in patients with local advanced laryngocarcinoma treated with or without IORT. | up to 1 month |