Comparing neck observation and elective neck dissection for early-stage oral cancer
Neck Observation Versus Selective Neck Dissection in Patients with CT1N0M0 Oral Squamous Cell Carcinoma: a Multicenter Randomized Controlled Trial
This study is testing whether watching the neck or doing surgery to remove lymph nodes is better for people with early-stage oral cancer in terms of survival and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06623266 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the outcomes of two different approaches for managing the neck in patients with early-stage oral squamous cell carcinoma (OSCC). Participants will undergo surgical resection of the primary tumor, with one group receiving elective neck dissection and the other group receiving neck observation. The study aims to assess the rates of lymph node metastasis, disease-free survival, overall survival, and quality of life over a two-year period. A total of 300 patients will be recruited for this trial, with equal distribution between the two treatment arms.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with cT1N0M0 oral squamous cell carcinoma located in specific oral sites such as the tongue, gingiva, or floor of the mouth.
Not a fit: Patients with multiple lesions, previous neck dissection, or a history of head and neck radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective neck management strategy for patients with early-stage oral cancer, potentially reducing unnecessary surgeries and improving quality of life.
How similar studies have performed: Previous studies have suggested that elective neck dissection may not improve survival in similar patient populations, indicating that this trial could provide valuable insights into neck management strategies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Huashan Hospital, Fudan University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Lai-ping Zhong, MD, PhD — Huashan Hospital
- Study coordinator: Lai-ping Zhong, MD, PhD
- Email: zhonglp@hotmail.com
- Phone: +862152888915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.