Sentinel Lymph Node Biopsy vs Neck Dissection for Oral Cancer

Recruiting at 93 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: NRG Oncology

Must not be taking: Cytotoxic chemotherapy, Immunosuppressive therapy

Disqualifiers: Metastatic disease, Prior neck surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

686 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a sentinel lymph node biopsy is more effective than the usual neck dissection surgery for treating early-stage oral cavity cancer. Sentinel lymph node biopsy targets and removes fewer lymph nodes, specifically those most likely to be affected, while standard neck dissection removes many lymph nodes. Suitable candidates for this trial have early-stage oral cavity cancer, such as cancer of the tongue or floor of the mouth, and have not undergone prior neck surgery. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sentinel lymph node biopsy (SLNB) reliably and effectively manages early-stage oral cancers. Studies indicate that SLNB accurately identifies affected lymph nodes, allowing treatment without excessive removal. This method is safe and well-tolerated, involving fewer invasive procedures than traditional surgery.

Data supports SLNB's safety, demonstrating its reliability in assessing early-stage oral cancers. It results in fewer side effects and complications by targeting only necessary lymph nodes, unlike more extensive neck surgeries. Although medical procedures always carry risks, current evidence suggests SLNB is a safer and less invasive option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about comparing Sentinel Lymph Node (SLN) Biopsy and neck dissection for oral cancer because these approaches offer different potential benefits. Unlike traditional neck dissection, which involves removing multiple lymph nodes, SLN biopsy targets only the first few nodes to which cancer is most likely to spread. This technique can reduce surgery-related complications and recovery time. SLN biopsy also uses advanced imaging techniques to precisely identify the relevant lymph nodes, which might improve accuracy in staging cancer.

What evidence suggests that this trial's treatments could be effective for oral cancer?

Research shows that sentinel lymph node biopsy (SLNB), one of the treatment options in this trial, works well for early-stage oral cavity cancer. Studies have found that SLNB can accurately identify cancerous lymph nodes in patients. One study detected cancer in 24.6% of cases, a significant finding. This method is particularly beneficial for patients with oral squamous cell carcinoma (OSCC) who do not show obvious signs of cancer in their lymph nodes. It helps avoid the unnecessary removal of many lymph nodes. By focusing only on the affected nodes, SLNB may cause fewer side effects than traditional neck surgery. Overall, evidence supports SLNB as a reliable option for treating early-stage oral cancer. The trial will also compare SLNB with elective neck dissection (END), another treatment arm, to evaluate their effectiveness and outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Stephen Y Lai

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Patients undergo either sentinel lymph node biopsy or elective neck dissection surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

Up to 11 years

3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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 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

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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 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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10969103/

Sentinel Lymph Node Biopsy (SLNB) for Early-Stage Head ...

Results revealed 24.6% SLN biopsy positivity, with 169 SLNs resected and a 21.9% positivity ratio. The study suggests SLNB's reliability for T1- ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1368837525004270

Sentinel lymph node biopsy in early-stage oral squamous ...

Sentinel lymph node biopsy (SLNB) is an effective method for managing clinically node-negative (cN0) early-stage oral squamous cell carcinoma (OSCC).

3.

nrgoncology.org

nrgoncology.org/hn006

NRG-HN006: SLN Biopsy for ES Oral Cavity Cancer

NRG-HN006 is a clinical study that seeks to determine if patient-reported neck and shoulder function and related quality of life is better six months after ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9314893/

Efficacy of different sentinel lymph node biopsy protocols in ...

The sentinel node biopsy (SNB) is highly protocolized in other cancers, however, this is not the case for oral squamous cell carcinoma patients.

5.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.21.02781

Should Sentinel Lymph Node Biopsy Be Considered the ...

Should sentinel lymph node biopsy be considered the new standard of care for early-stage clinically node-negative oral squamous cell carcinoma?

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2834497/

Sentinel Lymph Node Biopsy Accurately Stages the Regional ...

The mean depth of invasion of the primary oral cancer was 0.85 cm for patients with positive lymph nodes and 0.72 cm with negative lymph nodes, which was not a ...