IORT in Local Advanced Laryngocarcinoma (ILAL)

Tianjin First Central Hospital

Status: Unknown

Conditions: Laryngeal Neoplasms

Treatments: Procedure: surgery; Radiation: IORT; Radiation: External radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04278638

2019008

Details and patient eligibility

About

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 .

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

with IORT

Experimental group

Treatment:

Procedure: surgery

Radiation: IORT

Radiation: External radiotherapy

without IORT

Active Comparator group

Treatment:

Procedure: surgery

Radiation: External radiotherapy