Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

Launched by HUASHAN HOSPITAL · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatment approaches for patients with early-stage oral cancer, specifically oral squamous cell carcinoma (OSCC) that has not spread to the lymph nodes. The study aims to find out how these approaches affect the chances of lymph node metastasis (cancer spreading to lymph nodes), overall survival, and quality of life over a two-year period. Participants will either have surgery to remove the primary tumor along with an elective neck dissection (removal of lymph nodes) or just surgery for the tumor itself.

To be eligible for the trial, participants should be between 18 and 90 years old, have a diagnosis of early-stage OSCC in specific areas of the mouth, and meet other health criteria. Those who have multiple tumors, a recent history of other cancers, or certain medical conditions may not be able to participate. If you join the study, you can expect regular follow-ups to monitor your health and receive support throughout the process. This trial is currently recruiting participants, and it aims to help improve treatment options for future patients with oral cancer.

Gender

ALL

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