Laryngeal Neoplasms
Conditions
Brief summary
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 .
Interventions
RADIATIONIORT
IORT in surgery of laryngocarcinoma
PROCEDUREsurgery
total laryngectomy or hemilaryngectomy
RADIATIONExternal radiotherapy
External radiotherapy
Sponsors
Tianjin First Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. adults over the age of 18; 2. radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines); 3. the expected survival time ≥ 3 months; 4. sign informed consent for treatment and research with self-knowledge.
Exclusion criteria
1. there is distant metastasis; 2. pregnant women; 3. patients with CT/MRI contraindications; 4. the patient fails to receive treatment and/or follow-up as scheduled; 5. bad fluid and organ function decompensation; 6. multiple primary cancers; 7. patients participating in other trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year local recurrence rate | 2 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tissue necrosis | 2 years | 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-year disease free survival | 2 years | 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. |
| fibrosis | 2 years | 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. |
| time of wound healing | up to 1 month | Compare the time of wound healing after surgery in patients with local advanced laryngocarcinoma treated with or without IORT. |
| 2-year overall survival | 2 years | Compare 2-year overall survival in patients with local advanced laryngocarcinoma treated with or without IORT. |
Other
| Measure | Time frame | Description |
|---|---|---|
| pharyngeal fistula | 3 months | Pharyngeal fistula means that saliva is stored in subcutaneous or subincisional tissues, resulting in abscess cavity rupture to the skin or incision margin, making the hypopharyngeal and esophageal lumen communicate with the skin to form a sinus tract, through which saliva or food can spill out to the skin, forming a skin fistula. |
Countries
China
Contacts
Primary ContactXinyuan Gong
Outcome results
None listed