IORT in Local Advanced Laryngocarcinoma (ILAL)

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Neoplasms
• Intervention / Treatment: Radiation: IORT; Procedure: surgery; Radiation: External radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyuan Gong; Phone Number: +8613436640313; Email: gxy0007@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Tianjin First Central Hospital
      • Contact: Xinyuan Gong; Phone Number: +8613436640313; Email: gxy0007@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: with IORT	Radiation: IORT; IORT in surgery of laryngocarcinoma; Procedure: surgery; total laryngectomy or hemilaryngectomy; Radiation: External radiotherapy; External radiotherapy
ACTIVE_COMPARATOR: without IORT	Procedure: surgery; total laryngectomy or hemilaryngectomy; Radiation: External radiotherapy; External radiotherapy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tianjin First Central Hospital

Publications and helpful links

General Publications

• Yang Y, Li L, Zheng Y, Liu Q, Wei X, Gong X, Wang W, Lin P. A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol. BMC Cancer. 2020 Aug 6;20(1):734. doi: 10.1186/s12885-020-07233-1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (ACTUAL): February 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngeal Neoplasms
• Other Study ID Numbers: 2019008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No