A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Neck Dissection for cN0 Supraglottic Laryngeal Cancer

Laryngeal Neoplasms Clinical Trial

Official title:

A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Selective Neck Dissection for Clinically Negative Neck of Supraglottic Laryngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392220
• Other study ID #: CH-H&N-009
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2018
• Last updated: January 6, 2018
• Start date: October 1, 2016
• Est. completion date: March 1, 2022

Study information

• Verified date: January 2018
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Xiaolei Wang, MD
• Phone: 8610-87787180
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Supraglottic laryngeal carcinoma patients with clinically negative neck (cN0) will be randomized divided into two groups. Patients in case group will undergo unilateral neck dissection (II-IV) while bilateral neck dissection (II-IV) in control group. Regional control rate is the primary endpoint and comparison will be made to see if unilateral dissection can get similar regional control as control group.

Description:

Some retrospective analysises showed the low local recurrence rate of patients who accepted unilateral neck dissection with cN0 supraglottic laryngeal carcinoma. The aim of this study is to see if unilateral dissection can get similar regional control as bilateral dissection.

308 patients with cN0 supraglottic laryngeal carcinoma will be enrolled in five centers of northern China. Patients will be randomly assigned to 1: 1 ratio case group or control goup. Patients in case group will undergo unilateral (laryngeal primary tumor affected side) neck dissection (II-IV) while bilateral neck dissection (II-IV) in control group. And other necessary standard treatments will be performed in both case group and control group.Allowed by the patients, the investigators will obtain archived tumor specimens and 10ml peripheral blood samples from the patients before surgery.

The patients will be followed-up every three months after surgery, until three years after surgery or develop regional recurrence. During the follow-up procedure, radiological evaluation will be performed. The primary end point is the patient's pathologically confirmed regional lymph node recurrence. Patients with primary end point will enter the overall survival follow-up stage. At the median follow-up time of two years, the investigators will undergo a major regional control rate analysis, then, all patients will be followed-up to five years postoperatively, and the overall survival analysis will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: March 1, 2022
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. The patients obtain informed consent prior to any trial.

2. Diagnosis: Histopathology was confirmed to be squamous cell carcinoma. Classified by laryngoscopy as supraglottic, no tongue and deep pharyngeal invasion, and subglottic invasion. Also, no distant signs of metastasis.

3. Primary lesion is limited to one side, violation or more than midline, but preoperative laryngoscopy and CT can still clearly distinguish between the severity of bilateral lesions.

4. Evaluation of cN0: Patients need to undergo neck palpation, ultrasound and enhanced CT, if the patient is allergic to CT enhancer, replace it with MRI.Not touch more than 2cm hard lymph nodes in the neck, moreover, ultrasound and enhanced CT are not found lymph node that diameter = 1cm.Or, the size does not meet the above criteria, but find rim enhancement, central irregular or hypodensity, and with the surrounding tissue boundary is obscure, and other suspicious transfer signs.

5. After multidisciplinary discussion, the preferred treatment for patients is surgical treatment.

6. Patients with no other previous head and neck cancer, and neck did not receive radiation therapy, no deep neck surgery, skin resection excepted.

Exclusion Criteria:

1. Laryngeal carcinoma but not squamous cell carcinoma, or primary pathology includes non-squamous cell components.

2. Preoperative laryngoscopy assessment of primary lesions just in the middle or both sides of symmetry, can not distinguish which side is more serious.

3. No surgical indications, or initial treatment evaluation recommends non-surgical treatment.

4. The patient had other head and neck cancer.

Related Conditions & MeSH terms

• Laryngeal Neoplasms
• Malignant Neoplasm of Supraglottis Primary
• Neck Dislocation
• Neoplasms

Intervention

Procedure:
• Unilateral Neck Dissection
patient undergo unilateral (affected side) neck dissection, along with the excision of the laryngeal primary tumor
• Bilateral Neck Dissection
patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Science	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Hebei Medical University Fourth Hospital, Jilin Provincial Tumor Hospital, Liaoning Tumor Hospital & Institute, The first affiliated hospital of Jinzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local-regional control	The local-regional control time is defined as the time from the primary surgery to any confirmed local-regional(neck) lymph node metastasis. The metastasis should be confirmed by both image examination( ultra-sound/CT/MRI etc.) and pathology examination. The primary outcome measure is to compare the unilateral neck dissection group's local-regional control time with the bilateral neck dissection group. The local control benefit of the two groups is evaluated.	3 years
Secondary	Progression free survival, Overall survival	The progression free survival and the overall survival of the two groups of patients are being measured and compared with one and other, so the survival benefit of the two policy is evaluated.	5 years