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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

ConditionsBuccal Mucosa Squamous Cell CarcinomaFloor of Mouth Squamous Cell CarcinomaGingival Squamous Cell CarcinomaHard Palate Squamous Cell CarcinomaLip Squamous Cell CarcinomaLower Alveolar Ridge Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaRetromolar Trigone Squamous Cell CarcinomaStage I Lip and Oral Cavity Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Tongue Squamous Cell CarcinomaUpper Alveolar Ridge Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNRG Oncology

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (SCC) of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration

History/physical examination within 42 days prior to registration

Imaging of head and neck within 42 days prior to registration

PET/CT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic quality CT is preferred and highly recommended as part of the PET/CT when possible

Disqualifiers

Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease

Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years

Diagnosis of head and neck SCC in the oropharynx, nasopharynx, hypopharynx, and larynx

Unable or unwilling to complete NDII (baseline only)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chest Radiography

    Procedure/Surgery

    Undergo chest x-ray

  • Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT scan and FDG PET/CT or CT

  • Fludeoxyglucose F-18

    Other intervention

    Undergo FDG PET/CT

  • Imaging Agent

    Drug

    Receive imaging agent via injection

  • Neck Dissection

    Procedure/Surgery

    Undergo standard elective neck dissection

  • Planar Imaging

    Procedure/Surgery

    Undergo planar imaging

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo FDG PET/CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Sentinel Lymph Node Biopsy

    Procedure/Surgery

    Undergo SLN biopsy

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT scan

Treatment groups

686 Participants
are divided into 2 treatment groups
Group A: Group I (SLN biopsy)Experimental treatment 9 interventions
Group B: Group II (END)Active comparator 5 interventions

Trial outcomes

Primary outcomes

1

Patient-reported neck and shoulder function (Phase II/III)

Will be evaluated and compared using the Neck Dissection Impairment Index (NDII), a 10-item tool between the two treatment arms. It is assumed that a 7.5-point between arm difference in the 6-month post-surgery NDII scores is clinically meaningful.

Time frame
Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
2

Patient reported quality of life (QOL) (Phase II)

Will be measured using 3 questionnaires over 12-15 minutes.

Time frame
Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
3

Disease-free survival (DFS) (phase III)

Measured using Cox proportional hazards model and the Kaplan-Meier method. Failure includes local/regional recurrence, distant metastasis, or death due to any cause.

Time frame
From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years

Secondary outcomes

1

Overall survival rate

Will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.

Time frame
From randomization to death due to any cause, assessed up to 11 years
2

Loco-regional failure

The cumulative incidence estimator will be used to estimate time to event distributions with between arm differences using cause-specific log-rank test.

Time frame
From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 11 years
3

Distant metastasis

The cumulative incidence estimator will be used to estimate event distributions with between arm differences tested using cause-specific log-rank test.

Time frame
From the time of randomization to the date of distant metastasis, date of precluding event, or last known follow-up date, assessed up to 11 years
4

Toxicity

Measured by the Common Terminology Criteria for Adverse Events version 5.0. The proportion of patients with at least 1 grade 3 or higher adverse event will be compared between treatment arms.

Time frame
Time of primary endpoint analysis

Other outcomes

1

Quality of life

Measured by European Quality of Life Five Dimension Five Level Scale Questionnaire.

Time frame
Baseline, 3 weeks, and 3, 6, 12 months post-surgery
2

DFS for low-risk patients

Exploratory analyses will be done using the Kaplan-Meier method to estimate the DFS distribution in both arms. Cox proportional hazards models with the treatment arm only and with treatment arms and relevant patient and tumor characteristics will be fitted. 95% confidence intervals (CIs) for the treatment effect from both models will be also reported.

Time frame
From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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