Clinical trial NCT03392220: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngeal Neoplasms
Malignant Neoplasm of Supraglottis Primary
Neck Dislocation
Keywords: clinically negative neck
regional control rate
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Liaoning Cancer Hospital & Institute
name: Hebei Medical University Fourth Hospital
name: Jilin Provincial Tumor Hospital
name: The First People's Hospital of Jingzhou
First posted: 2018-01-05
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Local-regional control
timeFrame: 3 years
Secondary outcomes:
measure: Progression free survival, Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Science
name: Xiaolei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: