Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

NCT06623266 | Recruiting

• 1 other identifier: Acromion
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Lymph Node Metastasis

Keywords

Oral squamous cell carcinoma; Early stage; Neck dissection; Neck observation; Lymph node metastasis rate

Outcome Measures

Primary Outcomes (1)

• Rate of 2-year lymph node metastasis

  Lymph node metastasis is confirmed by pathological examinations, using fine needle aspiration cytology or biopsy. The rate of 2-year lymph node metastasis rate is reported as the percentage of patients who are free from lymph node metastasis for 2 years from the date of randomization.

  2 years

Secondary Outcomes (3)

• Rate of 2-year disease free survival

  2 years

• Rate of 2-year overall survival

  2 years

• Health-related quality of life

  2 years

Study Arms (2)

Experimental arm

PLACEBO COMPARATOR

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.

Procedure: Neck management

Control arm

ACTIVE COMPARATOR

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.

Procedure: Neck management

Interventions

Neck management 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; Experimental arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms; Lymphatic Metastasis; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Lai-ping Zhong, MD, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai-ping Zhong, MD, PhD

CONTACT

+862152888915; zhonglp@hotmail.com

Liang Gu, MD

CONTACT

+862152889999; guliang@hotmail.com

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

Model Details: Randomized 1:1 to the experimental or 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.

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 14, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years after completion of the trial, for 6 months.
• Access Criteria: Data can be obtained upon scientifically sound request from the study PI, who will contact the Clinical Research Unit, Huashan Hospital, Fudan University. Access will be released after the approval from the Clinical Research Unit.

Locations

CN (1)