Sentinel Lymph Node Biopsy vs Neck Dissection for Oral Cancer

Recruiting at 97 trial locations

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. ^{1 2 3 4 5}

What 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. ^{1 4 5 6 7}

Is 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. ^{2 5 6 8 9}

Research Team

Stephen Y Lai

Principal Investigator

NRG Oncology

Eligibility 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

I've been mostly active and able to care for myself in the last 42 days.

Ability to read and understand English

My primary tumor was removed through my mouth.

Exclusion Criteria

I have had surgery on the side of my neck.

Currently participating in another investigational therapeutic trial

My cancer has spread to other parts of my body.

Treatment Details

Interventions

• Computed Tomography (CT) (Procedure)
• Imaging Agent (Drug)
• Neck Dissection (Procedure)
• Planar Imaging (Procedure)
• Sentinel Lymph Node Biopsy (Procedure)
• Single Photon Emission Computed Tomography (Procedure)

Trial Overview 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.

Participant Groups

Group I: Group I (SLN biopsy) Experimental Treatment 9 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 Control 5 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 Canada, Japan, China, Switzerland for the following indications:

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

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Sentinel lymph node biopsy (SLNB) shows fewer complications and better physical outcomes compared to elective neck dissection in early oral cancer, based on a systematic review of 13 studies.

While SLNB is associated with improved measures like scar appearance and shorter hospital stays, the evidence for better health-related quality of life outcomes is inconclusive due to methodological issues in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. McDonald, C., Kent, S., Schache, A., et al.[2023]

Sentinel node biopsy (SNB) is emerging as a potential alternative to elective neck dissection (END) in early oral cancers, but current evidence suggests that END is still necessary during primary resection for cN0 oral cancers based on recent randomized trials.

The false negative rate of SNB may be comparable to the regional failure rate after END for pN0 necks, indicating that while SNB could reduce the number of neck dissections, there is still uncertainty regarding its techniques, protocols, and overall benefits compared to END.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical Review of the Current Evidence on Sentinel Node Biopsy in Oral Cancer. Singh, A., Roy, S., Tuljapurkar, V., et al.[2022]

In a study of 132 patients with T1-T2N0M0 oral cavity squamous cell carcinoma, those with macrometastasis (tumor size ≥ 2 mm) or two or more metastatic sentinel lymph nodes (SLNs) had significantly worse overall survival and disease-free survival rates.

The analysis of 418 SLNs revealed that the size and number of metastatic SLNs are critical factors in determining prognosis, with macrometastasis showing a hazard ratio of 4.85 for overall survival, indicating a strong association with poorer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macroscopic and multiple metastases in sentinel lymph node biopsy are respectively associated with poor prognosis in early oral cancer. Kondo, T., Tsukahara, K., Kawakita, D., et al.[2023]

A systematic review of five observational studies found no significant differences in neck recurrence rates, overall survival, or disease-free survival between sentinel node biopsy (SNB) and elective neck dissection (END) in patients with T1-T2 oral cancer and clinically negative necks.

SNB may offer advantages over END, such as lower rates of postoperative complications and shoulder dysfunction, but the overall quality of evidence is low, highlighting the need for more rigorous randomized studies to inform clinical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy versus elective neck dissection in early-stage oral cancer: a systematic review. Crocetta, FM., Botti, C., Pernice, C., et al.[2022]

Sentinel node biopsy (SNB) has been validated as a safe and effective alternative to elective neck dissection for staging early-stage oral squamous cell carcinomas (OSCC), supported by recent large-scale trials and long-term follow-ups.

SNB is associated with fewer complications and lower morbidity compared to traditional methods, and advancements like real-time molecular assessments are enhancing its accuracy and expanding its use in other areas of head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy for early oral carcinoma. Stoeckli, SJ., Broglie, MA.[2012]

Sentinel lymph node (SLN) biopsy can be beneficial for patients with small T1 oral cavity squamous cell carcinoma who are not candidates for elective neck treatment, as it helps identify potential micrometastases.

In a study of 13 patients, SLN biopsy revealed micrometastases in 2 cases, leading to selective neck dissection without further metastases found, and all patients remained recurrence-free after at least 12 months of follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy as an alternative to wait and see policy in patients with small T1 oral cavity squamous cell carcinoma. Keski-Säntti, H., Kontio, R., Leivo, I., et al.[2014]

A survey of 352 Indian surgeons revealed that while 82.6% still prefer elective neck dissection (END) for managing early oral cancer, 76.4% acknowledge that sentinel node biopsy (SNB) could lead to better shoulder function.

Challenges to the routine use of SNB include high costs, lack of expertise and infrastructure, longer procedure times, a higher false negative rate, and the potential need for a second surgery, indicating that further improvements are needed before SNB can become a standard treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in early oral cancers: are we ready for it yet? Results from a survey among Indian surgeons treating oral cancers. Malik, A., Dhar, H., Vaidya, A., et al.[2023]

In a study of 296 oral cancer patients, skip metastasis was observed in 10 patients, indicating that some may have metastasis in lymph nodes that are not directly connected to the primary tumor, which raises concerns about the effectiveness of traditional lymph node dissection.

Sentinel lymph node biopsy (SLNB) using blue dye was successful in detecting sentinel nodes in 17 out of 21 patients, with a high accuracy rate of 94%, suggesting that SLNB could be a valuable tool for accurately staging oral cancer and potentially reducing unnecessary surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of sentinel lymph node biopsy with squamous cell carcinoma of the oral cavity. Minamikawa, T., Umeda, M., Komori, T.[2019]

Sentinel lymph node biopsy (SLNB) is technically feasible for early oral cavity squamous cell carcinoma (OCSCC) in Australia, with a 100% negative predictive value, indicating it can accurately identify patients without cancer in the lymph nodes.

In this study of 30 patients, SLNB successfully retrieved all sentinel nodes, and 50% were pathologically positive, demonstrating its effectiveness in detecting at-risk lymphatic basins, even those outside traditional dissection areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy for early oral cancers: Westmead Hospital experience. Abdul-Razak, M., Chung, H., Wong, E., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Critical Review of the Current Evidence on Sentinel Node Biopsy in Oral Cancer. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Macroscopic and multiple metastases in sentinel lymph node biopsy are respectively associated with poor prognosis in early oral cancer. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy versus elective neck dissection in early-stage oral cancer: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy for early oral carcinoma. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy as an alternative to wait and see policy in patients with small T1 oral cavity squamous cell carcinoma. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Reliability of sentinel lymph node biopsy with squamous cell carcinoma of the oral cavity. [2019]

9. Australia pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy for early oral cancers: Westmead Hospital experience. [2017]