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

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ClinicalTrials.gov Identifier: NCT03392220
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Liaoning Tumor Hospital & Institute
Hebei Medical University Fourth Hospital
Jilin Provincial Tumor Hospital
The First People's Hospital of Jingzhou
Information provided by (Responsible Party):
Wang Xiaolei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Laryngeal Neoplasms Malignant Neoplasm of Supraglottis Primary Neck Dislocation Procedure: Unilateral Neck Dissection Procedure: Bilateral Neck Dissection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Selective Neck Dissection for Clinically Negative Neck of Supraglottic Laryngeal Carcinoma
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Local-regional control [ Time Frame: 3 years ]
    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 :
  1. Progression free survival, Overall survival [ Time Frame: 5 years ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392220


Contacts
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Contact: Xiaolei Wang, MD 8610-87787180
Contact: Jie Liu, MD 8610087787180

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Science Recruiting
Beijing, Beijing, China, 100021
Contact: Xiaolei Wang, MD    8610-87787180      
Contact: Jie Liu, MD    8610-87787180      
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Liaoning Tumor Hospital & Institute
Hebei Medical University Fourth Hospital
Jilin Provincial Tumor Hospital
The First People's Hospital of Jingzhou
Investigators
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Principal Investigator: Xiaolei Wang, MD Cancer Hospital, Chinese Academy of Medical Science

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Responsible Party: Wang Xiaolei, Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03392220     History of Changes
Other Study ID Numbers: CH-H&N-009
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wang Xiaolei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
clinically negative neck
regional control rate
Additional relevant MeSH terms:
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Laryngeal Neoplasms
Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases