Sentinel Lymph Node Biopsy vs Neck Dissection for Oral Cancer
Recruiting in Palo Alto (17 mi)
+97 other locations
Overseen ByStephen Y Lai
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: NRG Oncology
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy, you may not be eligible to participate.
What data supports the idea that Sentinel Lymph Node Biopsy vs Neck Dissection for Oral Cancer is an effective treatment?
The available research shows that Sentinel Lymph Node Biopsy (SLNB) is gaining popularity as an alternative to Elective Neck Dissection (END) for early oral cancer. Studies suggest that SLNB may improve survival rates with fewer complications compared to END. A systematic review found that SLNB might offer better health-related quality of life and functional outcomes. Additionally, SLNB is supported by numerous studies as a standard care option, indicating its effectiveness in treating early-stage oral cancer.
12345What safety data exists for sentinel lymph node biopsy vs neck dissection in oral cancer?
Sentinel lymph node biopsy (SNB) is considered oncologically safe for early oral cancer and may have less morbidity compared to elective neck dissection (END). Studies and systematic reviews suggest SNB as a viable alternative to END, with comparable outcomes in terms of survival and neck recurrence rates. However, SNB is not yet fully validated to replace END in all cases, and its routine use may present challenges.
14567Is Sentinel Lymph Node Biopsy a promising treatment for oral cancer compared to Neck Dissection?
Yes, Sentinel Lymph Node Biopsy is a promising treatment for oral cancer. It is gaining popularity as an alternative to Neck Dissection because it can be more selective and may reduce surgery-related complications. Many studies support its use as a standard care option for early oral cancers.
25689Eligibility Criteria
This trial is for adults with early-stage oral cavity cancer, including cancers of the tongue, floor of mouth, and other areas within the oral cavity. They must be candidates for surgery through a transoral approach and have no evidence of distant metastatic disease. Pregnant or breastfeeding women are excluded, as well as those with severe co-morbidities or who have had certain prior treatments.Inclusion Criteria
My primary tumor was removed through my mouth.
I have been diagnosed with squamous cell carcinoma in my mouth.
Exclusion Criteria
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 a history of blood cancer.
I am currently on specific medical treatments.
I have received chemotherapy for my current cancer.
My oral surgery didn't remove all cancer, and cancer cells were found at the edge of the removed tissue.
Participant Groups
The study compares sentinel lymph node biopsy (SLNB) to standard neck dissection in treating early-stage oral cavity cancer. SLNB uses an imaging agent to identify key lymph nodes for removal, potentially offering a less extensive surgery than traditional neck dissection which removes many lymph nodes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (SLN biopsy)Experimental Treatment9 Interventions
Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
Group II: Group II (END)Active Control5 Interventions
Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
Neck Dissection is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Neck Dissection for:
- Head and neck cancers
- Oral cavity cancers
🇺🇸 Approved in United States as Neck Dissection for:
- Head and neck cancers
- Oral cavity cancers
🇨🇦 Approved in Canada as Neck Dissection for:
- Head and neck cancers
- Oral cavity cancers
🇯🇵 Approved in Japan as Neck Dissection for:
- Head and neck cancers
- Oral cavity cancers
🇨🇳 Approved in China as Neck Dissection for:
- Head and neck cancers
- Oral cavity cancers
🇨🇭 Approved in Switzerland as Neck Dissection for:
- Head and neck cancers
- Oral cavity cancers
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Memorial Sloan Kettering MonmouthMiddletown, NJ
Sanford Cancer Center Oncology ClinicSioux Falls, SD
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, FL
Providence Portland Medical CenterPortland, OR
More Trial Locations
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Who is running the clinical trial?
NRG OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Health-related quality of life, functional outcomes, and complications after sentinel lymph node biopsy and elective neck dissection in early oral cancer: A systematic review. [2023]Elective neck dissection improves survival in early oral cancer. Sentinel lymph node biopsy may also do this with less morbidity. This systematic review compared health-related quality of life, functional outcomes, and complications after sentinel lymph node biopsy and elective neck dissection in early oral cancer.
Critical Review of the Current Evidence on Sentinel Node Biopsy in Oral Cancer. [2022]With contemporary surgery of the cN0 neck in early oral cancer becoming more selective, sentinel node biopsy (SNB) is gaining popularity as a possible alternate option to elective neck dissection (END). This review attempts to critically appraise the current evidence and highlight pertinent arguments for the use of SNB in early oral cancers.
Macroscopic and multiple metastases in sentinel lymph node biopsy are respectively associated with poor prognosis in early oral cancer. [2023]A multicenter, randomized controlled phase III trial was conducted on sentinel lymph node biopsy (SLNB) and elective neck dissection for T1 (depth of invasion ≥ 4 mm)-T2N0M0 oral cavity squamous cell carcinoma. This study identified factors associated with poor prognosis in patients who underwent SLNB based on a subgroup analysis of this trial.
Sentinel node biopsy versus elective neck dissection in early-stage oral cancer: a systematic review. [2022]To provide a summary of the evidence on the comparative effectiveness of two surgical treatment strategies, sentinel node biopsy (SNB) and elective neck dissection (END), in patients with T1-T2 oral cancer and clinically negative (cN0) neck, in terms of overall survival (OS), disease-free survival (DFS) and neck recurrence rates (NRRs).
Sentinel node biopsy for early oral carcinoma. [2012]Sentinel node biopsy (SNB) in oral squamous cell carcinomas (OSCCs) has been under investigation since more than a decade. Numerous published studies and recent important scientific data support its role as an alternative standard of care apart from elective neck dissection.
Sentinel lymph node biopsy as an alternative to wait and see policy in patients with small T1 oral cavity squamous cell carcinoma. [2014]Although sentinel lymph node (SLN) biopsy is not yet validated for clinical use to replace elective neck dissection in patients with oral squamous cell carcinoma, it can be recommended for patients who do not fulfil the criteria for elective neck treatment according to current treatment protocols.
Sentinel lymph node biopsy in early oral cancers: are we ready for it yet? Results from a survey among Indian surgeons treating oral cancers. [2023]Emerging evidence has shown that sentinel node biopsy (SNB) is an oncologically safe option in patients with early oral cancer compared with elective neck dissection (END). However, its use on a routine basis could be associated with many challenges.
Reliability of sentinel lymph node biopsy with squamous cell carcinoma of the oral cavity. [2019]Although sentinel lymph node biopsy (SLNB) may reduce surgery-related complications related to unnecessary lymph node dissection and is now widely used for many patients with cutaneous melanoma and breast cancer, its use for oral cancer patients remains controversial. One of the main reasons for the reluctance to initiate SLNB for oral cancer is that the frequency of skip metastasis has not been clarified. The objectives of this study are to examine the frequency of skip metastasis and to evaluate SLNB for oral cancer.
Sentinel lymph node biopsy for early oral cancers: Westmead Hospital experience. [2017]Sentinel lymph node biopsy (SLNB) has become an alternative option to elective neck dissection (END) for early oral cavity squamous cell carcinoma (OCSCC) outside of Australia. We sought to assess the technical feasibility of SLNB and validate its accuracy against that of END in an Australian setting.