Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

NCT ID: NCT06623266

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2028-09-30

Brief Summary

To evaluate the clinical outcomes of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life in the patients with cT1N0M0 oral squamous cell carcinoma, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only.

Detailed Description

For the patients with cT1N0M0 oral squamous cell carcinoma (OSCC), surgical resection of primary lesion is the preferred treatment. However, there are still debates on the neck management, some surgeons suggest elective neck dissection (END), and some surgeons suggest neck observation (NOB). The advantage of elective neck dissection is to clear the potential occult neck lymph node metastasis (about 15%), which could not be detected by clinical examination and imaging examination, and the disadvantage of END is to cause neck deformity, large scars, stiff neck and shoulders, difficulty in raising shoulders, and increase medical costs. The disadvantage of NOB is the risk of lymph node metastasis and disease progression. However, recent retrospective studies show that END has no potential benefit in improving survival in cT1N0M0 patients. The aim of the present trial is to compare the clinical outcomes between the cT1N0M0 OSCC patients, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only, on the aspects of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life. A total number of 300 patients will be recruited, including 150 patients in the experimental arm and 150 patients in the control arm. Experimental arm: radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Control arm: radical resection of the primary lesion with 1.0-1.5cm safety margins, and elective neck dissection. A complete medical history will be obtained and tumor assessment will be performed at baseline. Patients will be followed-up by every three months in the first 2 years, every six months in the next 3-5 years, and once a year thereafter until death or data censoring. Two-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life will be collected and analyzed.

Conditions

Oral Cancer; Lymph Node Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

The patients in the experimental arm will receive radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Ultrasonography, CT scan, and/or MRI examination will be used to detect lesions.

Group Type: PLACEBO_COMPARATOR

Neck management

Intervention Type: PROCEDURE

In the experimental arm: the neck management is neck observation, simultaneous elective neck dissection is not performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.

In the control arm: the neck management is elective neck dissection. Simultaneous elective neck dissection is performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.

Control arm

The patients in the control arm will receive radical resection of the primary lesion with the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion, they will also receive simultaneous elective neck dissection. Ultrasonography, CT scan, and/or MRI examination will be used to detect lesions.

Group Type: ACTIVE_COMPARATOR

Neck management

Intervention Type: PROCEDURE

In the experimental arm: the neck management is neck observation, simultaneous elective neck dissection is not performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.

In the control arm: the neck management is elective neck dissection. Simultaneous elective neck dissection is performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.

Interventions

Neck management

In the experimental arm: the neck management is neck observation, simultaneous elective neck dissection is not performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.

In the control arm: the neck management is elective neck dissection. Simultaneous elective neck dissection is performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara
• Clinical stage is cT1N0M0 (AJCC 8th edition)
• Pathological diagnosis of squamous cell carcinoma
• Sign the informed consent form

Exclusion Criteria

• More than 2 lesions found in the oral cavity
• Known history of malignant tumor within five years (unless the patient has undergone curative treatment and there is no disease recurrence within 5 years since the start of treatment)
• History of unilateral or bilateral neck dissection in the past
• History of previous head and neck radiotherapy
• Pregnant or lactating women
• Severe, uncontrolled infection or known HIV infection; or previous organ transplantation, stem cell or bone marrow transplantation
• Participated in other clinical studies within 30 days before enrollment
• Other circumstances that the researcher considers unsuitable for participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lai-ping Zhong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lai-ping Zhong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lai-ping Zhong, MD, PhD

Role: CONTACT

zhonglp@hotmail.com

+862152888915

Liang Gu, MD

Role: CONTACT

guliang@hotmail.com

+862152889999 ext. 7182

Facility Contacts

Lai-ping Zhong, MD, PhD

Role: primary

zhonglp@hotmail.com

+862152888915

Liang Gu, MD

Role: backup

kqyxyhyy@163.com

+862152889999 ext. 7182

Jing-song Li, MD, PhD

Role: backup

Xue-kui Liu, MD, PhD

Role: backup

Lei Tao, MD, PhD

Role: backup

Yu Wang, MD, PhD

Role: backup

Can-hua Jiang, MD, PhD

Role: backup

Li-song Lin, MD, PhD

Role: backup

Jian Meng, MD, PhD

Role: backup

Wen-bo Yang, MD

Role: backup

Liang Gu, MD

Role: backup

Hui-yong Zhu, MD, PhD

Role: backup

Yan-ming Liu, MD, PhD

Role: backup

Chao Chen, MD, PhD

Role: backup

Lei Xie, MD, PhD

Role: backup

Fa-yu Liu, MD, PhD

Role: backup

Chuan-yu Hu, MD, PhD

Role: backup

Jian-bo Xu, MD

Role: backup

Can Xiao, MD, PhD

Role: backup

Tian-shu Xu, MD

Role: backup

Kai Yin, MD

Role: backup

Yong-hong Zhang, MD

Role: backup

Yu-lin Jia, MD, PhD

Role: backup

Wei-jie Dong, MD

Role: backup

Zhi-en Feng, MD, PhD

Role: backup

Cheng-zhe Yang, MD, PhD

Role: backup

Other Identifiers

Acromion

Identifier Type: -

Identifier Source: org_study_id