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Laryngeal Cancer

Supraglottic Laryngeal Cancer

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

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

patient undergo unilateral (affected side) neck dissection, along with the excision of the laryngeal primary tumor

Unilateral Neck Dissection

Bilateral Neck Dissection

Xiaolei Wang, MD

Jie Liu, MD

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.

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.

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

A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Selective Neck Dissection for Clinically Negative Neck of Supraglottic Laryngeal Carcinoma

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.

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.

Liaoning Tumor Hospital & Institute

Hebei Medical University Fourth Hospital

Jilin Provincial Tumor Hospital

The First People's Hospital of Jingzhou

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Professor

Mouth and Tooth Diseases

Carcinoma, Squamous Cell

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.

modified neck dissection

traditional neck dissection without preservation of submandibular gland

traditional neck dissection

Jia-Zeng Su, Dr.

Guang-Yan Yu, Professor

Trial design: a randomized controlled trial.

Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.

Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.

Primary Parameters: survival rate, mortality rate

Submandibular Gland Preservation in Neck Dissection

Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Neck Dissection for cN0 Supraglottic Laryngeal Cancer	NCT03392220	Laryngeal Neopl... Malignant Neopl... Neck Dislocatio...	Unilateral Neck... Bilateral Neck ...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Submandibular Gland Preservation in Neck Dissection	NCT03385720	Neck Dislocatio... Oral Cancer	modified neck d... traditional nec...	- 90 Years	Peking University

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