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

Primary Purpose

Laryngeal Neoplasms, Malignant Neoplasm of Supraglottis Primary, Neck Dislocation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Unilateral Neck Dissection

Bilateral Neck Dissection

About this trial

This is an interventional treatment trial for Laryngeal Neoplasms focused on measuring clinically negative neck, regional control rate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patients obtain informed consent prior to any trial.
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.
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.
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.
After multidisciplinary discussion, the preferred treatment for patients is surgical treatment.
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:

Laryngeal carcinoma but not squamous cell carcinoma, or primary pathology includes non-squamous cell components.
Preoperative laryngoscopy assessment of primary lesions just in the middle or both sides of symmetry, can not distinguish which side is more serious.
No surgical indications, or initial treatment evaluation recommends non-surgical treatment.
The patient had other head and neck cancer.

Sites / Locations

Cancer Hospital, Chinese Academy of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

undergo bilateral neck dissection (II-IV)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03392220

First Posted

January 2, 2018

Last Updated

January 6, 2018

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Liaoning Tumor Hospital & Institute, Hebei Medical University Fourth Hospital, Jilin Provincial Tumor Hospital, The First People's Hospital of Jingzhou

1. Study Identification

Unique Protocol Identification Number

NCT03392220

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2016 (Actual)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Liaoning Tumor Hospital & Institute, Hebei Medical University Fourth Hospital, Jilin Provincial Tumor Hospital, The First People's Hospital of Jingzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laryngeal Neoplasms, Malignant Neoplasm of Supraglottis Primary, Neck Dislocation

Keywords

clinically negative neck, regional control rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

undergo bilateral neck dissection (II-IV)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Unilateral Neck Dissection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Bilateral Neck Dissection

Intervention Description

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

Primary Outcome Measure Information:

Title

Local-regional control

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Progression free survival, Overall survival

Description

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.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patients obtain informed consent prior to any trial. 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. 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. 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. After multidisciplinary discussion, the preferred treatment for patients is surgical treatment. 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: Laryngeal carcinoma but not squamous cell carcinoma, or primary pathology includes non-squamous cell components. Preoperative laryngoscopy assessment of primary lesions just in the middle or both sides of symmetry, can not distinguish which side is more serious. No surgical indications, or initial treatment evaluation recommends non-surgical treatment. The patient had other head and neck cancer.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaolei Wang, MD

Phone

8610-87787180

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Liu, MD

Phone

8610087787180

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaolei Wang, MD

Organizational Affiliation

Cancer Hospital, Chinese Academy of Medical Science

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital, Chinese Academy of Medical Science

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaolei Wang, MD

Phone

8610-87787180

First Name & Middle Initial & Last Name & Degree

Jie Liu, MD

Phone

8610-87787180

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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