Status:
UNKNOWN
A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Neck Dissection for cN0 Supraglottic Laryngeal Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Liaoning Cancer Hospital & Institute
Hebei Medical University Fourth Hospital
Conditions:
Laryngeal Neoplasms
Malignant Neoplasm of Supraglottis Primary
Eligibility:
All Genders
18-75 years
Phase:
NA
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 b...
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 uni...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT03392220
Start Date
October 1 2016
End Date
March 1 2022
Last Update
January 9 2018
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021