IORT in Local Advanced Laryngocarcinoma

Not Applicable

• Conditions: Laryngeal Neoplasms
• Interventions: Procedure: surgery; Radiation: IORT; Radiation: External radiotherapy

• Registration Number: NCT04278638
• Lead Sponsor: Tianjin First Central Hospital

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23
• Primary Completion: 2022-07-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with IORT	External radiotherapy	-
without IORT	surgery	-
without IORT	External radiotherapy	-
with IORT	IORT	-
with IORT	surgery	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
2-year overall survival	2 years	Compare 2-year overall survival in patients with local advanced laryngocarcinoma treated with or without IORT.
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.
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.

Trial Locations

Locations (1)

Tianjin First Central Hospital; 🇨🇳 Tianjin, Tianjin, China