Comparing Sentinel Lymph Node Biopsy with Standard Neck Surgery for Early-Stage Oral Cavity Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04333537

Provider View

This study is exploring whether a less invasive surgery called sentinel lymph node biopsy is as effective as the standard neck surgery for treating early-stage oral cavity cancer. The goal is to see if this approach can improve recovery and quality of life for patients.

Patient Parameters

Program Overview

This clinical trial is investigating two different surgical methods for treating early-stage oral cavity cancer. The first method, sentinel lymph node biopsy, involves removing fewer lymph nodes by using an imaging agent to identify which nodes are most likely to contain cancer. The second method, standard neck dissection, involves removing more lymph nodes. The study aims to determine if the less invasive sentinel lymph node biopsy is as effective as the standard method in treating cancer and improving patients' quality of life.

Description

The main goals of this study are to see if patients have better neck and shoulder function and quality of life six months after surgery when they have sentinel lymph node biopsy compared to standard neck surgery. The study also aims to find out if the cancer-free survival rate is similar between the two methods. Researchers will compare how often the cancer returns and overall survival rates between the two groups. They will also look at the side effects of each surgery and how long patients stay in the hospital. The study will involve two groups: one group will have sentinel lymph node biopsy, and the other will have standard neck surgery. Patients will be followed up regularly after surgery to monitor their recovery and health.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the oral cavity, including areas like the tongue, floor of the mouth, or gums.
  • Cancer must be in an early stage (T1-2N0M0) based on specific medical tests.
  • Must be a candidate for surgery, including sentinel lymph node biopsy and possibly further neck surgery.
  • Good overall health with a performance status of 0-2.
  • Women of childbearing potential must have a negative pregnancy test.
  • Must be able to read and understand English to complete required questionnaires.
  • Must provide informed consent to participate in the study.
  • Must complete a specific questionnaire before randomization.

Exclusion Criteria

  • Evidence of cancer spread to other parts of the body.
  • History of other invasive cancers unless disease-free for at least 2 years.
  • Diagnosis of head and neck cancer in areas other than the oral cavity.
  • Unable or unwilling to complete required questionnaires.
  • Previous chemotherapy or radiation that would affect the study area.
  • Severe health conditions that prevent surgery.
  • Pregnant or breastfeeding women.
  • Incomplete removal of the oral cavity lesion with positive margins.
  • Previous neck surgery that would interfere with the trial.
  • History of blood disorders or other diseases causing lymph node swelling.
  • Currently receiving certain cancer treatments or participating in another trial.

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