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

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

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.

Study Overview

• Status: Unknown
• Conditions: Laryngeal Neoplasms; Malignant Neoplasm of Supraglottis Primary; Neck Dislocation
• Intervention / Treatment: Procedure: Unilateral Neck Dissection; Procedure: Bilateral Neck Dissection

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaolei Wang, MD; Phone Number: 8610-87787180
• Study Contact Backup: Name: Jie Liu, MD; Phone Number: 8610087787180

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital, Chinese Academy of Medical Science
      • Contact: Xiaolei Wang, MD; Phone Number: 8610-87787180
      • Contact: jie liu, MD; Phone Number: 8610-87787180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: undergo unilateral (affected side) neck dissection (II-IV); patient undergo affected side neck dissection, along with the excision of the laryngeal primary tumor	Procedure: Unilateral Neck Dissection; patient undergo unilateral (affected side) neck dissection, along with the excision of the laryngeal primary tumor
Experimental: undergo bilateral neck dissection (II-IV); patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor	Procedure: Bilateral Neck Dissection; patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Jilin Provincial Tumor Hospital; Hebei Medical University Fourth Hospital; Liaoning Tumor Hospital & Institute; The First People's Hospital of Jingzhou
• Investigators: Principal Investigator: Xiaolei Wang, MD, Cancer Hospital, Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 6, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: clinically negative neck; regional control rate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Laryngeal Diseases; Neoplasms; Laryngeal Neoplasms
• Other Study ID Numbers: CH-H&N-009

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