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

NCT ID: NCT03392220

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2022-03-01

Brief 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.

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.

Conditions

Laryngeal Neoplasms; Malignant Neoplasm of Supraglottis Primary; Neck Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

undergo unilateral (affected side) neck dissection (II-IV)

patient undergo affected side neck dissection, along with the excision of the laryngeal primary tumor

Group Type: EXPERIMENTAL

Unilateral Neck Dissection

Intervention Type: PROCEDURE

patient undergo unilateral (affected side) neck dissection, along with the excision of the laryngeal primary tumor

undergo bilateral neck dissection (II-IV)

patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor

Group Type: EXPERIMENTAL

Bilateral Neck Dissection

Intervention Type: PROCEDURE

patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor

Interventions

Unilateral Neck Dissection

patient undergo unilateral (affected side) neck dissection, along with the excision of the laryngeal primary tumor

Intervention Type: PROCEDURE

Bilateral Neck Dissection

patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: collaborator

Jilin Provincial Tumor Hospital

OTHER

Sponsor Role: collaborator

Jinzhou Medical University

OTHER

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Wang Xiaolei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaolei Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science

Locations

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaolei Wang, MD

Role: CONTACT

8610-87787180

Jie Liu, MD

Role: CONTACT

8610087787180

Facility Contacts

Xiaolei Wang, MD

Role: primary

8610-87787180

Jie Liu, MD

Role: backup

8610-87787180

Other Identifiers

CH-H&N-009

Identifier Type: -

Identifier Source: org_study_id