A Multicenter, Randomized, Case-control Study of Unilater... | NCT03392220

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

NCT03392220

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Jan 9, 2018Actual

Enrollment

308Estimated

Phase

Not Applicable

Conditions

Laryngeal Neoplasms
Malignant Neoplasm of Supraglottis Primary
Neck Dislocation

Interventions

Unilateral Neck Dissection
Bilateral Neck Dissection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Mar 1, 2022Estimated

First Submitted Date

Jan 2, 2018

First Submission Date that Met QC Criteria

Jan 2, 2018

First Posted Date

Jan 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2018

Last Update Posted Date

Jan 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wang Xiaolei, Professor, Cancer Institute and Hospital, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical SciencesOTHER

Collaborators

Name	Class
Liaoning Cancer Hospital & Institute	OTHER
Hebei Medical University Fourth Hospital	OTHER
Jilin Provincial Tumor Hospital	OTHER
Jinzhou Medical University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

308Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
undergo unilateral (affected side) neck dissection (II-IV)	Experimental	patient undergo affected side neck dissection, along with the excision of the laryngeal primary tumor	Procedure: Unilateral Neck Dissection
undergo bilateral neck dissection (II-IV)	Experimental	patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor	Procedure: Bilateral Neck Dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unilateral Neck Dissection	Procedure	patient undergo unilateral (affected side) neck dissection, along with the excision of the laryngeal primary tumor	undergo unilateral (affected side) neck dissection (II-IV)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaolei Wang, MD	Contact	8610-87787180
Jie Liu, MD	Contact	8610087787180

Overall Officials

Name	Affiliation	Role
Xiaolei Wang, MD	Cancer Hospital Chinese Academy of Medical Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital, Chinese Academy of Medical Science	Recruiting	Beijing	Beijing Municipality	100021	China

ID	Term
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007818	Laryngeal Diseases
D012140	Respiratory Tract Diseases
D012142	Respiratory Tract Neoplasms
D010038	Otorhinolaryngologic Diseases