IORT in Local Advanced Laryngocarcinoma

Laryngeal Neoplasms Clinical Trial

— ILAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278638
• Other study ID #: 2019008
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2020
• Source: Tianjin First Central Hospital
• Contact: Xinyuan Gong
• Phone: +8613436640313
• Email: gxy0007[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laryngeal Neoplasms

Intervention

Radiation:
• IORT
IORT in surgery of laryngocarcinoma

Procedure:
• surgery
total laryngectomy or hemilaryngectomy

Radiation:
• External radiotherapy
External radiotherapy

Locations

Country	Name	City	State
China	Tianjin First Central Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin First Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pharyngeal fistula	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.	3 months
Primary	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	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
Secondary	2-year overall survival	Compare 2-year overall survival in patients with local advanced laryngocarcinoma treated with or without IORT.	2 years
Secondary	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
Secondary	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
Secondary	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