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Sentinel Lymph Node Biopsy vs Neck Dissection for Oral Cancer
Study Summary
This trial compares sentinel lymph node biopsy surgery to standard neck dissection for early-stage oral cavity cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I've been mostly active and able to care for myself in the last 42 days.My primary tumor was removed through my mouth.I have had surgery on the side of my neck.My cancer has spread to other parts of my body.My cancer is in my head or neck.I cannot or do not want to complete the NDII questionnaire.I have had cancer other than in the head or neck area in the last 2 years.I have had radiation therapy on the cancer area being studied.I have a serious health condition that prevents neck surgery.I have been diagnosed with squamous cell carcinoma in my mouth.I have a history of blood cancer.I am currently on specific medical treatments.I have received chemotherapy for my current cancer.My cancer stage fits the study requirements.My oral surgery didn't remove all cancer, and cancer cells were found at the edge of the removed tissue.I had a surgical assessment within the last 42 days.
- Group 1: Sentinel Lymph Node (SLN) Biopsy
- Group 2: Elective Neck Dissection (END)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people are being enrolled in this clinical trial?
"That is correct. The clinicaltrials.gov website says that the trial is recruiting patients. This particular study was posted on 7/8/2020 and was edited as recently as 8/12/2022. There are 64 locations enrolling a total of 618 participants."
Are new participants still being sought for this experiment?
"This is an active clinical trial that is currently recruiting participants, as shown on clinicaltrials.gov. The study was posted on 7/8/2020 and was most recently edited on 8/12/2022."
Could you tell me how many different hospitals are testing this new treatment?
"There are currently 64 active sites for this trial, with locations such as Harrison's Memorial Sloan Kettering Westchester, Stanford Cancer Institute Palo Alto in Palo Alto, and MD Anderson in Sugar Land."
What are the goals of this research?
"The main aim of this clinical trial is to assess Disease-Free Survival over a 6-month period, with secondary outcomes including Loco-regional Failure and Overall Survival. General quality of life will also be measured using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) scale."
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