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

NCT03392220 | Unknown DMC

• 1 other identifier: CH-H&N-009
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Neoplasms; Malignant Neoplasm of Supraglottis Primary; Neck Dislocation

Keywords

clinically negative neck; regional control rate

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Progression free survival, Overall survival

  5 years

Study Arms (2)

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

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)

Bilateral Neck Dissection PROCEDURE

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

undergo bilateral neck dissection (II-IV)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Liaoning Cancer Hospital & Institute: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Jilin Provincial Tumor Hospital: collaborator
• Jinzhou Medical University: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Xiaolei Wang, MD

  Cancer Hospital Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolei Wang, MD

CONTACT

8610-87787180

Jie Liu, MD

CONTACT

8610087787180

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: October 1, 2016
• Primary Completion: September 30, 2020
• Study Completion: March 1, 2022
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)